Tissue removal system

ABSTRACT

A tissue removal device includes an outer tubular member coupled to a housing and a having a tissue resection window, an inner tubular member slidably disposed within the outer tubular member, a tissue trap having a sealed interior in fluid communication with a vacuum chamber, an open proximal end of the inner tubular member being disposed within the tissue trap interior, and an actuator moveably coupled to the housing and operatively connected to a movable piston in the vacuum chamber, such that movement of the actuator relative to the housing generates a vacuum in the tissue trap.

RELATED APPLICATION DATA

The present application is a continuation of pending U.S. patentapplication Ser. No. 14/743,286, filed Jun. 18, 2015, which is acontinuation of U.S. patent application Ser. No. 13/589,003, filed Aug.17, 2012, now issued as U.S. Pat. No. 9,060,760, which claims thebenefit under 35 U.S.C. § 119 to U.S. Provisional Patent application No.61/524,991, filed Aug. 18, 2011. The foregoing applications are herebyincorporated by reference into the present application in theirentirety.

FIELD

The disclosure relates generally to methods, systems and devices forsurgical procedures, and relates more particularly to tissue removalsystems for the removal of uterine fibroids and other abnormalgynecological tissues.

BACKGROUND

There are many situations in which it is desirable to remove unwantedtissue from a patient. Uterine fibroids and uterine polyps represent twosuch types of unwanted tissue. Uterine fibroids are well-defined,non-cancerous tumors that are commonly found in the smooth muscle layerof the uterus. Uterine polyps are wispy masses that are commonly foundextending from the inner lining of the uterus. In many instances,uterine fibroids and uterine polyps can grow to be several centimetersin diameter and may cause symptoms like menorrhagia (prolonged or heavymenstrual bleeding), pelvic pressure or pain, and reproductivedysfunction. It is believed that uterine fibroids occur in a substantialpercentage of the female population, perhaps in at least 20 to 40percent of all women, and that uterine polyps occur in up to 10 percentof all women.

One type of treatment for uterine fibroids and uterine polyps ishysteroscopic resection. Hysteroscopic resection typically involvesinserting a hysteroscope (i.e., an imaging scope) into the uterusthrough the vagina, i.e., transcervically, and then cutting away theunwanted tissue from the uterus using a device delivered to the unwantedtissue by the hysteroscope. Hysteroscopic resections typically fall intoone of two varieties. In one variety, an electrocautery device in theform of a loop-shaped cutting wire is fixedly mounted on the distal endof the hysteroscope. The combination of the hysteroscope and theelectrocautery device is typically referred to as a resectoscope. Thetransmission of electrical current to the uterus with a resectoscope istypically monopolar, and the circuit is completed by a conductive pathto the power unit for the device through a conductive pad applied to thepatient's skin. In this manner, tissue is removed by contacting the loopwith the part of the uterus wall of interest. Examples of such devicesare disclosed, for example, in U.S. Pat. No. 5,906,615, inventorThompson, issued May 25, 1999.

In the other variety of hysteroscopic resection, an electromechanicalcutter is inserted through a working channel in the hysteroscope. Theelectromechanical cutter typically includes (i) a tubular member havinga window through which tissue may enter and (ii) a cutting instrumentpositioned within the tubular member for cutting the tissue that hasentered the tubular member through the window. In use, the cutter ispositioned near the part of the uterus wall of interest. Tissue is thendrawn, typically by suction, into the window, and then the tissue drawninto the window is cut with the cutting instrument. Examples of theelectromechanical cutter variety of hysteroscopic resection aredisclosed in, for example, U.S. Pat. No. 7,226,459, inventors Cesariniet al., issued Jun. 5, 2007; U.S. Pat. No. 6,032,673, inventors Savageet al., issued Mar. 7, 2000; U.S. Pat. No. 5,730,752, inventors Alden etal., issued Mar. 24, 1998; U.S. Patent Application Publication No. U.S.2009/0270898 A1, inventors Chin et al., published Oct. 29, 2009; U.S.Patent Application Publication No. U.S. 2009/0270812 A1, inventorsLitscher et al., published Oct. 29, 2009; U.S. Patent ApplicationPublication No. U.S. 2006/0047185 A1, inventors Shener et al., publishedMar. 2, 2006; and PCT International Publication No. WO 99/11184,published Mar. 11, 1999, all of which are incorporated herein byreference.

In both of the above-described varieties of hysteroscopic resection,prior to tissue removal, the uterus is typically distended to create aworking space within the uterus. Such a working space typically does notexist naturally in the uterus because the uterus is a flaccid organ. Assuch, the walls of the uterus are typically in contact with one anotherwhen in a relaxed state. The conventional technique for creating such aworking space within the uterus is to administer a fluid to the uterusthrough the hysteroscope under sufficient pressure to cause the uterusto become distended. Examples of the fluid used conventionally todistend the uterus include gases like carbon dioxide or, more commonly,liquids like water or certain aqueous solutions (e.g., a saline or otherphysiologic solution or a sugar-based or other non-physiologicsolution).

One of the benefits of fluid distension is the tamponade effect that thedistension fluid provides on resected vascular tissue. Since thedistension fluid is typically maintained at a pressure that exceeds thepatient's mean arterial pressure (MAP), the fluid pressure provided bythe distension fluid prevents the leakage of arterial blood from theresected tissue from flowing or oozing into the uterine cavity. Whenarterial blood flows or oozes into the cavity, it mixes with thedistension fluid and renders visualization more difficult and, if notconstrained, the flowing or oozing blood will force the suspension ofthe procedure. Thus, maintenance of fluid pressure above the intracavityarterial pressure is critical for the maintenance of a clear visualfield.

Nevertheless, one shortcoming with existing hysteroscopic tissue removalsystems, particularly of the electromechanical cutter variety, is thatit is often difficult to maintain fluid distension of the uterus duringthe resection procedure. This is because such systems typically employ avacuum source that continuously subjects the electromechanical cutter tosuction, even when the cutting mechanism of the electromechanical cutteris not switched on. The purpose of such suction is to draw tissue intothe cutter, typically through the window, and to facilitate the removalof resected tissue from the uterus. However, such suction also typicallyhas the unwanted effect of removing some of the distending fluid fromthe uterus along with the resected tissue. Moreover, because suction iscontinuously applied to the cutter, even when the cutting mechanism isnot being operated, fluid tends to be continuously removed from theuterus whenever the cutter is inserted into the patient. If such fluidcannot be replenished quickly enough, the fluid pressure within theuterus may drop to an undesired level. In particular, a steep drop inuterine fluid pressure will result in the leakage of blood into theuterine cavity, causing a loss of visualization and ultimately stoppageof the procedure if the surgeon can no longer properly visualize thetreatment site. Moreover, depending on the extent and speed of the dropin uterine fluid pressure, there may be a significant lapse of timebefore the uterine fluid pressure can be restored to a desired levelsuch that adequate visualization is possible. Such lapses in time areclearly undesirable as they interrupt the resection procedure, as wellas lengthen the overall time for the procedure and increase the riskthat distending fluid may be taken up by a blood vessel in the uterus,i.e., intravasation, which uptake may be quite harmful to the patient.

One approach to the above problem has been to provide theelectromechanical cutter with a mechanism actuated by an electricalswitch that causes the window in the cutter to be closed off when thecutting mechanism is turned off. In this manner, when the cuttingmechanism is switched off, distension fluid from the uterus cannotescape from the uterus through the resection window of the cutter, andadequate uterine fluid pressure may be maintained. Unfortunately,however, the cost of the aforementioned electrical switch, as well asthe cost of several other components of the cutter, may make the cost ofthe above-described electromechanical cutter prohibitive for certainprocedures, such as polypectomies, for which the costs covered by mostinsurers are typically relatively low.

SUMMARY

In accordance with one embodiment of the disclosed inventions, a tissueremoval device comprises a housing; an outer tubular member coupled tothe housing and having a distal portion including a tissue resectionwindow; an inner tubular member slidably disposed within the outertubular member and defining an inner lumen extending from an open distalend to an open proximal end, the open distal end comprising a cuttingedge to sever tissue extending through the tissue resection window; avacuum generation chamber disposed in the housing including a movablepiston disposed in the vacuum generation chamber; a tissue trap disposedin or coupled to the housing, the tissue trap defining a sealed interiorin fluid communication with the vacuum generation chamber via a one-wayvalve, so that air may be withdrawn from the tissue trap interior intothe vacuum generation chamber by movement of the piston in a firstdirection, while air is prevented from entering the tissue trap interiorfrom the vacuum generation chamber due to movement of the piston in asecond direction opposite the first direction, wherein the open proximalend of the inner tubular member is disposed within the tissue trapinterior; and an actuator moveably coupled to the housing andoperatively connected to the piston, such that movement of the actuatorrelative to the housing causes movement of the piston within the vacuumgeneration chamber, wherein the actuator may be selectively operativelycoupled to the inner tubular member, such that movement of the actuatorrelative to the housing also causes movement of the inner tubular memberrelative to the outer tubular member. A distal portion of the outertubular member is preferably configured for insertion through a workingchannel of an endoscopic instrument for positioning the tissue resectionwindow in an interior region of a patient's body.

The actuator may be coupled to the housing by a pinned connection,wherein rotation of the actuator about the pin moves the piston withinthe vacuum generation chamber, and selectively moves the inner tubularmember relative to the outer tubular member. In one embodiment, theactuator is selectively operatively coupled to the inner tubular memberby a slider having a first position relative to the housing in which theactuator is not operatively coupled to the inner tubular member, and asecond position relative to the housing in which the actuatormechanically engages the inner tubular member to cause the open distalend of the inner tubular member to move distally across the tissueresection window as the actuator is moved relative to the housing.

Alternatively, the actuator may comprise an actuation member that slidesaxially relative to the housing, wherein sliding the actuator along thehousing moves the piston within the vacuum generation chamber. Forexample, the vacuum generating actuation member may be a ring positionedaround tubular portion of the housing. The same or a different mechanismmay be used for selectively moving the inner tubular member relative tothe outer tubular member.

The device may further comprise a seal disposed within the tissue trapinterior and configured for engaging and sealing the open proximal endof the inner tubular member when the inner tubular member is in aproximally withdrawn position relative to the outer tubular member. Afirst spring may be provided that restores the actuator followingmovement of the actuator. A second spring may be provided to restore theinner tublular member to a proximally withdrawn position followingmovement of the inner tubular member caused by the actuator.

In another embodiment, a tissue removal device comprises a housing; anouter tubular member coupled to the housing and having a distal portionincluding a tissue resection window; an inner tubular member slidablydisposed within the outer tubular member and defining an inner lumenextending from an open distal end to an open proximal end, the opendistal end comprising a cutting edge to sever tissue extending throughthe tissue resection window; a vacuum generation chamber disposed in thehousing including a movable piston disposed in the vacuum generationchamber; a tissue trap disposed in or coupled to the housing, the tissuetrap defining a sealed interior in fluid communication with the vacuumgeneration chamber via a one-way valve, so that air may be withdrawnfrom the tissue trap interior into the vacuum generation chamber bymovement of the piston in a first direction, while air is prevented fromentering the tissue trap interior from the vacuum generation chamber dueto movement of the piston in a second direction opposite the firstdirection, wherein the open proximal end of the inner tubular member isdisposed within the tissue trap interior; an actuator moveably coupledto the housing by a pinned connection and operatively connected to thepiston, such that rotation of the actuator about the pin moves thepiston within the vacuum generation chamber, and wherein the actuatormay be selectively operatively coupled to the inner tubular member, suchthat movement of the actuator relative to the housing also causesmovement of the inner tubular member relative to the outer tubularmember; and a spring configured to restore the actuator following manualrotation of the actuator relative to the housing.

The actuator may be selectively operatively coupled to the inner tubularmember by a slider having a first position relative to the housing inwhich the actuator is not operatively coupled to the inner tubularmember, and a second position relative to the housing in which theactuator mechanically engages the inner tubular member to cause the opendistal end of the inner tubular member to move distally across thetissue resection window as the actuator is rotated relative to thehousing. The device may include a further spring configured to restorethe inner tublular member to a proximally withdrawn position followingmovement of the inner tubular member caused by the actuator. The devicemay further include a seal disposed within the tissue trap interior andconfigured for engaging and sealing the open proximal end of the innertubular member when the inner tubular member is in a proximallywithdrawn position relative to the outer tubular member. Preferably, adistal portion of the outer tubular member is configured for insertionthrough a working channel of an endoscopic instrument for positioningthe tissue resection window in an interior region of a patient's body.

In accordance with yet another embodiment, a tissue removal devicecomprises a housing; an outer tubular member having a proximal portionconnected to the housing, and a distal portion including a tissueresection window; an inner tubular member having a tissue cutting opendistal end disposed within the outer tubular member; and a manuallypowered actuation assembly operatively coupled to the inner tubularmember for moving the inner tubular member to move relative to the outertubular member to thereby cause the open distal end of the inner tubularmember to move distally across the tissue resection window for cuttingtissue extending through the resection window, wherein the actuationassembly is configured such that manual activation of the assemblycauses the inner tubular member to rotate and axially translate relativeto the resection window.

By way of non-limiting example, the actuation assembly may be a triggerpivotally coupled to the housing, wherein pivoting the trigger relativeto the housing causes the inner tubular member to move relative to theresection window. In one such embodiment, the trigger has a first enddisposed within the housing, a second end disposed outside of thehousing, the actuation assembly further comprising a drive gear mountedwithin the housing and operatively engaging a mating gear on the innertubular member. The actuation assembly may be configured such that theresection window is closed by a distal end portion of the inner tubularmember when the inner tubular member is stationary. In some embodiments,the device further comprises a tissue aspiration port formed by orcoupled to the housing and in fluid communication with an open proximalend of the inner tubular member.

In still another embodiment, a tissue removal system is provided,including a tissue cutting device having an outer tubular member havinga resection window and an inner tubular member disposed within the outertubular member and movable across the resection window for cuttingtissue extending therethrough. A motor is operatively coupled to theinner tubular member for moving the inner tubular member across theresection window, with a user-operable switch that activates anddeactivates the motor. A vacuum source is fluidly coupled to an openproximal end of the inner tubular member for continuously applyingsuction thereto, wherein the tissue cutting device further comprises amechanical arrangement for preventing suction from being applied throughthe resection window if the inner member is stationary.

Additional objects, as well as aspects, features and advantages, of thedisclosure are set forth in part in the description which follows, andin part will be obvious from the description or may be learned bypractice of the invention. In the description, reference is made to theaccompanying drawings which form a part thereof and in which is shown byway of illustration various embodiments for practicing the invention.The embodiments will be described in sufficient detail to enable thoseskilled in the art to practice the invention, and it is to be understoodthat other embodiments may be utilized and that structural changes maybe made without departing from the scope of the disclosed inventions.The following detailed description is, therefore, not to be taken in alimiting sense, and the scope of the disclosure is best defined by theappended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The above and other aspects and features of the disclosed embodimentswill become more apparent upon consideration of the following detaileddescription, taken in conjunction with the accompanying drawings, inwhich like reference characters refer to like parts throughout, and inwhich:

FIG. 1 is a perspective view of a first embodiment of a tissue removalsystem constructed according to the teachings of the disclosure;

FIGS. 2(a) and 2(b) are enlarged perspective and enlarged transversesection views, respectively, of the access device shown in FIG. 1, theaccess device of FIG. 2(b) being shown with a tissue removal deviceinserted thereinto;

FIGS. 3(a) through 3(d) are various views of the tissue cutting deviceshown in FIG. 1, the tissue cutting device being shown in FIGS. 3(a)through 3(c), together with the distal ends of the vacuum tube and thesheath covering the external drive shaft;

FIG. 4 is a fragmentary side view, partly in section, of a firstalternate embodiment of a tissue cutting device for use in the system ofFIG. 1;

FIGS. 5(a) and 5(b) are fragmentary longitudinal and transverse sectionviews, respectively, of a second alternate embodiment of a tissuecutting device for use in the system of FIG. 1;

FIG. 6 is a fragmentary side view, partly in section, of a thirdalternate embodiment of a tissue cutting device for use in system ofFIG. 1;

FIG. 7 is a fragmentary perspective view, broken away in part, of afourth alternate embodiment of a tissue cutting device for use in thesystem of FIG. 1;

FIGS. 8(a) and 8(b) are perspective and enlarged, fragmentary, topviews, respectively, of a fifth alternate embodiment of a tissue cuttingdevice for use in the system of FIG. 1;

FIGS. 9(a) through 9(c) are fragmentary exploded perspective,fragmentary longitudinal section, and transverse section views,respectively, of a sixth alternate embodiment of a tissue cutting devicefor use in the system of FIG. 1;

FIG. 10 is a fragmentary top view of a seventh alternate embodiment of atissue cutting device for use in the system of FIG. 1;

FIG. 11 is a fragmentary side view of an eighth alternate embodiment ofa tissue cutting device for use in the system of FIG. 1;

FIG. 12 is a fragmentary side view of a ninth alternate embodiment of atissue cutting device for use in the system of FIG. 1;

FIG. 13 is a fragmentary longitudinal section view of a tenth alternateembodiment of a tissue cutting device for use in the system of FIG. 1;

FIG. 14 is a fragmentary longitudinal section view of the inner tubularmember shown in FIG. 13;

FIG. 15 is a perspective view of a second embodiment of a tissue removalsystem constructed according to the teachings of the disclosure;

FIG. 16 is a perspective view of a third embodiment of a tissue removalsystem constructed according to the teachings of the disclosure;

FIG. 17 is an enlarged side view of the tissue cutting device shown inFIG. 16;

FIG. 18 is a side view of a first alternate embodiment of a tissuecutting device for use in the system of FIG. 16;

FIG. 18(a) is a fragmentary perspective view showing the helical gearsof FIG. 18;

FIG. 19 is a side view of a second alternate embodiment of a tissuecutting device for use in the system of FIG. 16;

FIG. 20 is a perspective view of a fourth embodiment of a tissue removalsystem constructed according to the teachings of the disclosure;

FIG. 21(a) is a partly exploded perspective view of the tissue cuttingdevice shown in FIG. 20, certain components of the device, such as thedevice housing, not being shown;

FIG. 21(b) is a rear view of the tissue cutting device shown in FIG.21(a);

FIG. 21(c) is a section view of the tissue cutting device shown in FIG.21(b) taken along line 1-1;

FIG. 21(d) is a fragmentary enlarged view of the circled area 2 of thetissue cutting device shown in FIG. 21(c);

FIGS. 21(e) through 21(g) show the tissue cutting device of FIG. 21(a)at different stages in its operation;

FIGS. 22(a) through 22(d) are fragmentary perspective in a rest state,fragmentary exploded perspective, fragmentary longitudinal section in arest state, and fragmentary longitudinal section in a rotating stateviews, respectively, of a first alternate embodiment of a tissue cuttingdevice for use in the system of FIG. 20;

FIGS. 23(a) through 23(f) are fragmentary perspective in a rest state,fragmentary exploded perspective, fragmentary longitudinal section in arest state, fragmentary longitudinal section in a rotating state,transverse sectional in a rest state, and transverse sectional in arotating state views, respectively, of a second alternate embodiment ofa tissue cutting device for use in the system of FIG. 20;

FIGS. 24(a) through 24(d) are fragmentary perspective in a rest state,fragmentary exploded perspective, fragmentary longitudinal section in arest state, and fragmentary longitudinal section in a rotating stateviews, respectively, of a third alternate embodiment of a tissue cuttingdevice for use in the system of FIG. 20;

FIGS. 25(a) through 25(d) are fragmentary perspective in a rest state,fragmentary partly exploded perspective, fragmentary longitudinalsection in a rest state, and fragmentary longitudinal section in arotating state views, respectively, of a fourth alternate embodiment ofa tissue cutting device for use in the system of FIG. 20;

FIG. 26(a) is a perspective view of yet another embodiment of a tissuecutting device;

FIGS. 26(b) and 26(c) are cross-sectional views of the tissue cuttingdevice in FIG. 26(a) in vacuum mode and cutting mode, respectively; and

FIGS. 27(a) and 27(b) are perspective and cross-sectional views,respectively, of a still further embodiment of a tissue cutting device.

DETAILED DESCRIPTION

The disclosure is described below primarily in the context of devicesand procedures optimized for performing one or more therapeutic ordiagnostic gynecological or urological procedures such as the removal ofuterine polyps or other abnormal uterine tissue. However, the devicesand related procedures of the disclosure may be used in a wide varietyof applications throughout the body, through a variety of accesspathways.

For example, the devices of the disclosure can be optimized for use viaopen surgery, less invasive access such as laparoscopic access, orminimally invasive procedures such as via percutaneous access. Inaddition, the devices of the disclosure can be configured for access toa therapeutic or diagnostic site via any of the body's natural openingsto accomplish access via the ears, nose, mouth, and via trans-rectal,urethral and vaginal approach.

In addition to the performance of one or more gynecological and urologicprocedures described in detail herein, the systems, methods, apparatusand devices of the disclosure may be used to perform one or moreadditional procedures, including but not limited to access and tissuemanipulation or removal from any of a variety of organs such as thebladder, breast, lung, stomach, bowel, esophagus, oral cavity, rectum,nasal sinus, Eustachian tubes, heart, gall bladder, arteries, veins, andvarious ducts. Routes of access include but are not limited totrans-cervical; trans-vaginal-wall; trans-uteral; trans-vesicle;trans-urethral; and other routes.

FIG. 1 is a perspective view of a first embodiment of a tissue removalsystem, the tissue removal system being constructed according to theteachings of the disclosure and being represented generally by referencenumeral 11. System 11 is particularly well-suited for removing uterinepolyps and other similar abnormal gynecological tissues. However, itshould be understood that system 11 is not limited to such a use and maybe used in other anatomies and for other purposes apparent to those ofordinary skill in the art.

System 11 comprises an access device 13. In the present embodiment,access device 13 may be a hysteroscope, wherein access to the patient'sbody is achieved through the cervix. However, access device 13 mayalternatively be any of a wide variety of other instruments, such asendoscopes, catheters, cannulas, and the like, and access may be gainedthrough other natural openings or orifices in the body, for example,ears, nose, mouth, via trans-rectal, urethral, vaginal, or thoughsurgical incision, or the like.

Access device 13, shown separately in FIGS. 2(a) and 2(b), may beconventional in construction for a hysteroscope and is shaped tocomprise a handle 14-1, which is adapted to be held in the hand of auser, and a shaft 14-2, which extends distally from handle 14-1 andwhose distal end is adapted to be removably inserted into a patient.Handle 14-1 is shaped to include a fluid input port 15, an illuminationinput port 17, an observation output port 19, and an instrument inputopening 21. In addition, access device 13 comprises a plurality ofchannels extending distally from handle 14-1 and continuinglongitudinally through shaft 14-2. The channels include a first channel23-1 and a second channel 23-2. First channel 23-1 is in fluidcommunication with fluid input port 15 and, at the same time, isaccessible through instrument input opening 21. In this manner, amedical instrument, such as a tissue removal device, may be insertedinto opening 21 and through first channel 23-1, with the unoccupiedremainder of first channel 23-1 being available to conduct distensionfluid. A rod lens 24 or other suitable light collecting means isdisposed in second channel 23-2, with the remainder of second channel23-2 being occupied by fiber optics 25 or other suitable lighttransmitting means.

System 11 also comprises a fluid supply 16 for supplying input port 15with distension fluid. Fluid supply 16 comprises a fluid-containingsyringe, a peristaltic pump, or another suitable fluid-dispensing devicecoupled to input port 15 through tubing 16-1. Fluid supply 16 maycomprise automated means (not shown) for dispensing inflow fluidtherefrom at a desired rate. System 11 additionally comprises a meansfor supplying illuminating light to the distal end using optical fibers25. The illumination supplying mechanism includes a light source 31 andan optical cable 33. Cable 33 comprises a first end optically coupled tolight source 31 and an opposite end optically coupled to illuminationinput port 17 of access device 13.

System 11 includes a mechanism for converting light signals transmittedfrom rod lens 24 in access device 13 into corresponding electricalsignals. The signal converting mechanism includes a camera 35 and anoptical cable 37. Optical cable 37 has a first end optically coupled toobservation output port 19 of access device 13 through an adapter 38 anda second end optically coupled to camera 35. System 11 also includes amonitor 39 electrically coupled to camera 35 via a cable 40, forconverting the electrical signals generated by camera 35 into images. Inthis manner, monitor 39 may be used to display real-time images of theuterus or other body part into which access device 13 has been inserted.System 11 further includes a tissue cutting device 41.

Referring to FIGS. 3(a) through 3(d), the tissue cutting device 41 maybe seen in greater detail. Device 41 has complementary left and righthousing halves 43-1 and 43-2, respectively, each of which is made of arigid polymer or other suitable material. Halves 43-1 and 43-2 arejoined together with screws 45 to form an elongated hollow housing 43comprising a rounded side wall 46, an open proximal end 47, and an opendistal end 49. Housing 43 may be bent or otherwise ergonomically shapedto fit comfortably in the hand of a user. A proximal cap 48 is mountedin proximal end 47, cap 48 being shaped to include a pair of lumens 48-1and 48-2. Lumen 48-1 may be used to receive, for example, an externaldrive shaft, and lumen 48-2 may be used to receive, for example, avacuum tube. A distal cap 50 is mounted in distal end 49, cap 50 beingshaped to include a lumen, which receives a pair of coaxial cuttingtubes.

A plurality of ribs 44 are integrally formed and appropriatelypositioned along the respective interior surfaces of halves 43-1 and43-2, ribs 44 providing structural reinforcement to housing 43 and beingused to align certain of the mechanical components that are positionedwithin housing 43.

An internal drive shaft 51 is provided and adapted for rotation aboutits longitudinal axis. Shaft 51, which may be an elongated unitarystructure made of a suitably rigid metal or polymer, is shaped toinclude a proximal end 53 and a distal end 55. Proximal end 53 of shaft51 is coaxially mounted over and fixed to the distal end 57 of anexternal drive shaft 59, external drive shaft 59 being inserted througha retainer 58 mounted in housing 43. In this manner, the rotation ofshaft 51 is mechanically coupled to the rotation of shaft 59. Distal end55 of shaft 51 is inserted through an opening 60 in an annular bushing61, which bushing 61 is matingly mounted on a rib 44-1 via acircumferential slot 62 provided in bushing 61.

Device 41 further comprises a translation drive shaft 65 adapted forrotation about its longitudinal axis. Shaft 65, which may be anelongated unitary structure made of a suitably rigid metal or polymer,is shaped to include a proximal end 67, an intermediate portion 69, anda distal end 71. Proximal end 67 of shaft 65 is coaxially mounted overand fixed to the distal end 55 of internal drive shaft 51. In thismanner, the rotation of shaft 65 is mechanically coupled to the rotationof shaft 51. Intermediate portion 69 is shaped to include a doublehelical portion comprising a right-handed threaded helical channel 72and a left-handed threaded helical channel 73. Helical channels 72 and73 may have identical or different pitches. Helical channels 72 and 73are smoothly blended together at their respective ends to form acontinuous groove so that there is a smooth transition from one helicalchannel to the other. Distal end 71 of shaft 65 is appropriatelydimensioned to be received within an opening 74 in an annular bushing75, which bushing 75 is matingly mounted on a rib 44-2 via acircumferential slot 76 provided in bushing 75. It should be noted that,although shaft 65 is adapted for rotation, shaft 65 is translationallystationary.

Device 41 further comprises a gear assembly 80 adapted for rotationabout its longitudinal axis. Gear assembly 80, which may be an elongatedunitary structure made of a suitably rigid metal or polymer, is shapedto include a proximal spur gear 81 and a distal tube portion 82. Gearassembly 80 is coaxially mounted over intermediate portion 69 of shaft65 in an area between the double helical portion and distal end 71, andgear assembly 80 is fixed to shaft 65 using a pin inserted radiallythrough tube portion 82 and into an opening provided in shaft 65. Inthis manner, the rotation of spur gear 81 is mechanically coupled to therotation of shaft 65.

Device 41 further comprises an oscillating translation assembly 91.Translation assembly 91, in turn, includes a carriage 92 and a channelengagement member 93. Carriage 92, which may be a unitary structure madeof a suitably rigid metal or polymer, is shaped to include a proximalportion 94, an intermediate portion 95, and a distal portion 96. Thetops of proximal portion 94 and distal portion 96 extend beyond the topof intermediate portion 95 and are shaped to include loops 97-1 and97-2, respectively, loops 97-1 and 97-2 being aligned with one another.A longitudinal bore 98-1 is provided near the bottom of carriage 92,bore 98-1 being appropriately dimensioned to coaxially receiveintermediate portion 69 of shaft 65 while permitting intermediateportion 69 to rotate freely therewithin. Channel engagement member 93,which may be a unitary structure made of a suitably rigid metal orpolymer, is shaped to include a base 99 and a pawl 100. Base 99 isdisposed in an opening 98-2 that extends downwardly from the top ofintermediate portion 95 into communication with bore 98-1, with pawl 100traveling within the double helical portion of shaft 65. In this manner,as shaft 65 rotates, pawl 100 continuously travels back and forththrough the double helical portion of shaft 65, thereby causing carriage92 to oscillate translationally.

As can be appreciated, the speed at which carriage 92 oscillatestranslationally may be varied, for example, by varying the translationallength of the double helical portion of shaft 65, the angles of channels72 and 73, the rotational speed of shaft 59, etc. As will be discussedfurther below, it may be desirable to operate device 41 so that carriage92 oscillates translationally at about 2.8 cycles per second.

Device 41 further comprises a shaft 102 adapted for rotation about itslongitudinal axis. Shaft 102, which may be an elongated, unitary,tubular structure made of a suitably rigid metal or polymer, is shapedto include a proximal portion 102-1 and a distal portion 102-2. Proximalportion 102-1 is inserted through loops 97-1 and 97-2 of carriage 92 andfreely rotates relative to loops 97-1 and 97-2. Distal portion 102-2 isin the form of an elongated spur gear. Distal portion 102-2 is engagedwith spur gear 81 of gear assembly 80 so that the rotation of spur gear81 causes the rotation of shaft 102. Distal portion 102-2 is elongatedso that it maintains engagement with spur gear 81 even as distal portion102-2 moves translationally relative to spur gear 81.

The speed at which distal portion 102-2 rotates (and, therefore, thespeed at which shaft 102 rotates) may be the same as or different thanthe speed at which spur gear 81 rotates, depending, for example, on therelative diameters of the two gears (the ratio of the rotational speedsof the two gears being inversely proportional to the ratio of thediameters of the two gears). Consequently, by appropriately dimensioningspur gear 81 and distal portion 102-2, one can achieve a desiredrotational speed, even where the rotational speed of the external driveshaft is fixed. For example, in the embodiment shown, distal portion102-2 has a diameter that is one-fourth the diameter of spur gear 81and, therefore, rotates four times as fast as gear 81. Therefore, if theexternal drive shaft has a speed of rotation of about 1500 rpm, gear 81would rotate at 1500 rpm and distal portion 102-2 would rotate at 6000rpm. As can be appreciated, the rotational speed of distal portion 102-2does not depend on the interaction of translation assembly 91 with thedouble helical portion of shaft 65; consequently, distal portion 102-2may attain higher or lower rotational speeds than would be possiblebased on the requirements of a desired translational speed.Notwithstanding the above, shaft 102 is translationally coupled tocarriage 92. Consequently, as carriage 92 oscillates translationally, sodoes shaft 102.

Device 41 further comprises a strain relief member 104, which may be aunitary tubular structure made of a rigid polymer or metal. The proximalend of strain relief member 104 is fixedly mounted in a retainer 105,which is mounted at the distal end of housing 43, with the distal end ofstrain relief member 104 extending distally from housing 43 for a shortdistance, such as, for example, approximately 2 inches.

Device 41 further comprises a cutting mechanism, which includes an outertubular member 106 and an inner tubular member 107. Inner tubular member107 moves rotationally and simultaneously oscillates translationallyrelative to outer tubular member 106 in a manner further describedbelow. Outer tubular member 106, which may be a unitary structure madeof a suitable plastic, is shaped to include an open proximal end, aclosed distal end 111, and a lumen 112 extending from the open proximalend to a point just prior to closed distal end 111. Member 106 iscoaxially mounted within strain relief member 104, with the proximal endof member 106 disposed within the proximal end of strain relief member104 and with distal end 111 of member 106 extending distally beyond thedistal end of strain relief member 104 for an extended distance, suchas, for example, five inches. The proximal end of member 106 is fixedwithin retainer 105.

Outer tubular member 106 includes a resection window 119 into whichtissue may be captured and drawn, window 119 being located proximate todistal end 111, such as, for example, 0.25 inch from distal end 111.Window 119 is shaped to include a proximal end 119-1 and a distal end119-2. Proximal end 119-1 slopes gradually upwardly proximally, anddistal end 119-2 slopes gradually upwardly distally. More specifically,window 119 may have a length of approximately 0.55 inch, proximal end119-1 may be a radial end having a radius of curvature of, for example,0.085 inch, and distal end 119-2 may be a radial end having a radius ofcurvature of, for example, 0.150 inch. Window 119 may extend over asubstantial portion of the circumference of tubular member 106, such as,for example, about 60% of the circumference.

Outer tubular member 106 may have an outer diameter less than about 5.5mm. However, in order to reduce the risk of injury to the patient and inorder to obviate the need for anesthesia to be administered to thepatient, outer tubular member 106 preferably has an outer diameter lessthan about 5 mm, more preferably less than 4 mm, even more preferablyless than 3 mm, and still even more preferably less than 2 mm. However,should device 41 be used in an operating room setting where generalanesthesia is available, the diameter of the outer tubular member 106could be increased to maximize tissue removal. In such a case, outertubular member 106 could have a diameter generally less than about 12mm, preferably less than about 11 mm, and, for certain applications,less than 10 mm. Depending on the particular clinical application, outertubular member 106 could be constructed having an outer diameter of nomore than about 9 mm, in some applications less than about 8 mm,preferably less than 7 mm, and more preferably less than 6 mm where ODis desirably minimized.

Inner tubular member 107, which may be an elongated one-piece structuremade of 300-series stainless steel, includes a proximal end 121, adistal end 122, and a longitudinal lumen 123. Distal end 122 may beshaped, for example, by grinding, to include an external bevel, such as,for example, an external bevel of approximately 20 degrees. Anintermediate length of inner tubular member 107 is coaxially receivedwithin shaft 102 and is fixedly coupled to shaft 102 for translationaland rotational movement therewith. Proximal end 121 of inner tubularmember 107 is slidably mounted within a vacuum tube connector 125, whichin turn is coupled to a vacuum tube 130 inserted through lumen 48-2 ofcap 48. An O-ring 126 is mounted within connector 125 to maintain a goodseal with inner tubular member 107. An annular bushing 128 mountedwithin housing 43 receives inner tubular member 107 and maintains itsalignment.

Tubular members 106 and 107 are arranged so that, when inner tubularmember 107 is in a fully retracted (i.e., proximal) position, distal end122 of inner tubular member 107 is withdrawn sufficiently to permittissue to enter window 119 (preferably with distal end 122 of innertubular member 107 positioned proximal to window 119), and so that, wheninner tubular member 107 is in a fully advanced (i.e., distal) position,distal end 122 of tubular member 107 is positioned distally of distalend 119-2 of window 119. In this manner, as inner tubular member 107 ismoved translationally and rotationally past window 119, tissue withinwindow 119 may be sheared. To promote such a shearing of tissue, theouter diameter of inner tubular member 107 may be just slightly less(e.g., about 0.002 inch) than the inner diameter of outer tubular member106.

Device 41 further comprises an indicator sleeve 128. Sleeve 128, whichmay be an elongated tubular member made of a material that is easilydistinguishable visually from strain relief member 104, is coaxiallymounted over strain relief member 104 and fixedly mounted thereto, witha proximal end 128-1 of sleeve 128 lying flush against the distal end ofhousing 43. An example of a material suitable for use as sleeve 128 maybe a white or colored length of shrink-wrap material. Sleeve 128 may bedimensioned so that, when device 41 is inserted into access device 13,distal end 128-2 of sleeve 128 is visible to a user until distal end 111of device 41 is advanced beyond the distal end of access device 13. Inother words, distal end 128-2 may be used to indicate when distal end111 of device 41 lies flush with the distal end of access device 13. Inthis manner, a user may safely control the position of the distal end ofdevice 41 and, therefore, keep it within access device 13 when insertingdevice 41 into a patient, thereby reducing the risks for lacerations andperforations during introduction of device 41.

System 11 further comprises a specimen container 141 and a vacuum source143. The proximal end of vacuum tube 130 is connected to a first port145 of container 141. The distal end of a tube 147 is connected to asecond port 149 of container 141, and the proximal end of tube 147 isconnected to vacuum source 143. In this manner, vacuum source 143 isused to apply suction to device 41, and any withdrawn tissue, liquids orsimilar matter suctioned through device 41 may be collected in container141.

System 11 further comprises a motor unit 151, which may include a motor(not shown) and electronics (not shown). A pneumatic foot switch 153 isfluidly coupled to a tube 155 which, in turn, is fluidly coupled to apneumatic switch 157 on motor unit 151. Foot switch 153 is used as apower switch to selectively activate or de-activate the motor withinunit 151. The proximal end of shaft 59 is mechanically coupled forrotation to the motor located within unit 151, and the distal end ofshaft 59 is inserted through opening 48-1 and coupled to internal shaft51 in the manner discussed above. A protective sheath 160 covers much ofthe length of shaft 59. Unit 151 further includes a vacuum sensor 161coupled to container 141 by a tube 163 so that the pressure withincontainer 141 may be monitored. In this manner, a sudden increase invacuum pressure may indicate that a clog has occurred. The presence of aclog may be indicated by an alarm (not shown) located on unit 151. Thedetection of a clog is often a clear indication that the furtheroperation of device 41 may only aggravate the clogging situation andthat a cessation of tissue removal may be necessary.

Unit 151 is configured to synchronize actuation of its motor withactuation of vacuum source 143. This may be done using a cable 165electrically connecting unit 151 and vacuum source 143. In this manner,turning on the motor will turn on vacuum source 143 at the same time.Correspondingly, vacuum source 143 is deactivated whenever the motor isnot turned on. Such an arrangement may ameliorate the above-discussedproblem of distension fluid being suctioned from the uterus throughdevice 41 even when device 41 is not actuated for cutting.

In use, the distal end of shaft 14-2 of access device 13 may be insertedtranscervically, i.e., through the vagina and the cervix, into theuterus of the patient. If desired, prior to insertion of shaft 14-2 intothe patient, the cervix may be gradually dilated in the conventionalmanner using obturators of increasing diameter. The uterus may be washedof blood or other debris that may be present by dispensing fluid fromfluid supply 16 first through port 15 and then through first channel23-1 of device 13. Fluid and debris present in the uterus may exit theuterus proximally through a removable outflow channel (not shown)inserted into channel 23-1 of device 13 and connected at its proximalend to container 141. When the washing procedure is complete, fluid maycontinue to be dispensed into the uterus in order to fluidly distend theuterus to a desired extent. With the uterus thus distended, accessdevice 13 may then be used to examine the interior of the uterus.

If polyps or like abnormalities are detected that one wishes to remove,tissue removal device 41 may be loaded into access device 13, i.e., byinserting the distal ends of outer tubular member 106 and inner tubularmember 107 distally through channel 23-1 of access device 13. Tissuecutting device 41 may then be manipulated so that window 119 of outertubular member 106 may be positioned in proximity to the polyp or othertargeted tissue. Next, foot switch 153 may be depressed, causing themotor within unit 151 to be actuated and also causing vacuum source 143to be actuated. The actuation of vacuum source 143 causes suction to beapplied to inner tubular member 107, thereby drawing tissue into outertubular member 106 through window 119. The actuation of the motor withinunit 151 causes inner tubular member 107 simultaneously to rotate and tooscillate back and forth translationally within outer tubular member106, thereby resulting in the cutting of the tissue that is drawnthrough window 119.

The cut tissue may then be suctioned from the patient through innertubular member 107 by means of the aforementioned suction and,thereafter, collected in container 141. Once the polyps or othertargeted tissues have been removed from the patient, foot switch 153 maybe released, causing vacuum source 143 and the motor within unit 151 tobe turned off. Tissue cutting device 41 and access device 13 may then beremoved from the patient. Tissue cutting device 41 may be designed to bea single use device. If so, device 41 may then be disconnected from tube130 and shaft 59 and disposed of properly.

It will be appreciated that, although the above discussion contemplatesusing access device 13 to introduce tissue cutting device 41 into theuterus, one may insert tissue cutting device 41 transcervically into theuterus without the use of access device 13. In such a situation, fluidmay be administered transcervically to the uterus by a fluid dispensingdevice in order to distend the uterus, and, thereafter, observation ofthe uterus may be accomplished, for example, by ultrasonic imaging usingan ultrasonic probe inserted transcervically into the uterus. Such anultrasonic probe may be separate from device 41 or may be integratedinto device 41. Alternatively, imaging of the uterus may be performed byMRI imaging.

Although one may vary one or more of the speed of rotational movement ofinner tubular member 107, the frequency of oscillating translationalmovement of inner tubular member 107, the advance ratio of inner tubularmember 107 (i.e., the ratio of the speed at which inner tubular member107 oscillates translationally to the speed at which inner tubularmember 107 rotates), and the magnitude of suction provided by vacuumsource 143, the following conditions are preferred: speed of rotation ofinner tubular member 107—at least 1100 rpm, more preferably at least5000 rpm, even more preferably approximately 6000 rpm; frequency ofoscillating translational movement of inner tubular member 107—at least1.5 cycles per second, more preferably about 2.5 to 4 cycles per second,even more preferably about 2.8 cycles per second; advance ratio ofpreferably less than 0.25, more preferably less than 0.15; and vacuumpressures in the range of 200 to 650 mmHg. The above parameters may beselected to achieve a rate of tissue removal of at least 1.5 gm/minwhile outer tubular member 106 has an outer diameter of no greater thanabout 3.0 mm.

As can also be appreciated, as suction is applied to inner tubularmember 107, some of the distension fluid located in the uterus mayincidentally be withdrawn from the uterus through inner tubular member107. This loss of distension fluid from the uterus may be undesirable ifit interferes with maintenance of the uterus in an adequately distendedstate. System 11 may be constructed and operated so that, with a vacuumin excess of 300 mmHg, a volume of no more than about 300 cc/min offluid is removed. This may be achieved, as in the present embodiment, byapplying suction only when the motor for moving inner tubular member 107is actuated. Alternatively, this may be achieved by having somearrangement for closing window 119 with inner tubular member 107 eachtime the motor control is stopped. Examples of such arrangements arediscussed later in this application.

FIG. 4 is a fragmentary side view, partly in section, of a firstalternate embodiment of a tissue cutting device for use in system 11,the first alternate embodiment being represented generally by referencenumeral 180. Device 180 is similar in many respects to device 41, onedifference between the two devices being that, whereas device 41comprises an outer tubular member 106 and an inner tubular member 107,device 180 comprises an outer tubular member 181 and a cutter 183. Outertubular member 181 is similar in most respects to outer tubular member106, the principal difference between the two tubular members beingthat, whereas outer tubular member 106 may be made of molded plastic,outer tubular member 181 may be made of stainless steel or anothersimilarly suitable material.

Outer tubular member 181 includes a window 184, similar in size andshape to window 119, through which a polyp or similar tissue may bedrawn. Cutter 183 comprises a proximal portion 185 and a distal portion187, proximal portion 185 and distal portion 187 being securely joinedto one another in an end-to-end fashion, for example, using a suitableadhesive. Proximal portion 185 comprises a tube, which may be made ofextruded plastic, and may correspond in length to a majority of thelength of inner tubular member 107. Distal portion 187, which may bemade, for example, by injection molding, comprises a tubular portion 189and a serrated edge 191. In use, a polyp or similar tissue may be drawn,by suction, into the interior of outer tubular member 181 through window184. The tissue may then be cut by serrated edge 191 as cutter 183 movesacross the interior of window 184. The severed tissue may then beremoved, by suction, through the hollow interior of cutter 183.

FIGS. 5(a) and 5(b) depict fragmentary longitudinal and transversesection views of a second alternate embodiment of a tissue cuttingdevice for use in system 11, the second alternate embodiment beingrepresented generally by reference numeral 194. Device 194 is similar inmost respects to device 41. One difference between the two devices isthat, whereas device 41 comprises outer tubular member 106 and innertubular member 107, device 194 includes an outer tubular member 195 anda cutter 197. Outer tubular member 195 is similar to outer tubularmember 106 (or to outer tubular member 181 of device 180), except thatouter tubular member 195 is D-shaped in transverse cross-section. Outertubular member 195 includes a window 196, through which a polyp orsimilar tissue may be drawn. Cutter 197 comprises a proximal portion 198and a distal portion 199, proximal portion 198 and distal portion 199being securely joined to one another in an end-to-end fashion bysuitable means. Proximal portion 198 comprises a tube and may correspondin length to a majority of the length of inner tubular member 107.Distal portion 199 comprises a razor blade. In use, a polyp or similartissue may be drawn, by suction, into the interior of outer tubularmember 195 through window 196.

The tissue may then be cut by distal portion 199 as distal portion 199moves across the interior of window 196. The severed tissue may then beremoved, by suction, through the hollow interior of proximal portion198. As can be appreciated, since rotational movement of cutter 197 isnot desired, structure corresponding to distal portion 102-2 and spurgear 81 of device 41 may be omitted from device 194.

FIG. 6 is a fragmentary side view, partly in section, of a thirdalternate embodiment of a tissue cutting device for use in system 11,the third alternate embodiment being represented generally by referencenumeral 200. Device 200 is similar in many respects to device 41, onedifference between the two devices being that, whereas device 41comprises outer tubular member 106 and inner tubular member 107, device200 comprises an outer tubular member 201 and a cutter 203. Outertubular member 201 is similar, for example, to outer tubular member 106(or to outer tubular member 181 of device 180). Cutter 203 is in theform of an auger. In use, tubular member 201 may be positioned so that apolyp or similar tissue extends into the interior of tubular member 201through window 205. The tissue may then be cut and moved proximallythrough the interior of tubular member 201 by the rotational movement of203.

As can be appreciated, device 200 may obviate the need for the use ofsuction in system 11. Therefore, when using device 200, componentsrelating to a vacuum source in system 11 may be omitted. In addition,since oscillating translational movement of cutter 203 may not bedesired, those components of tissue removal device 41 used to provideoscillating translational movement may be omitted from device 200.

FIG. 7 is a fourth alternate embodiment of a tissue cutting device foruse in system 11, the fourth alternate embodiment being representedgenerally by reference numeral 241. Device 241 is similar in mostrespects to device 41, the principal difference between the two devicesbeing that device 241 additionally includes a tissue trap 243 disposedwithin housing 43. Tissue trap 243 is appropriately coupled to tube 130to collect tissue from those materials suctioned through tube 130.

FIGS. 8(a) and 8(b) illustrate yet another alternate embodiment of atissue removal device for use in system 11, the fifth alternateembodiment being represented generally by reference numeral 261. Devicemay 261 is similar in many respects to device 41, the principaldifference between the two devices being that, whereas device 41comprises, amongst other things, outer tubular member 106, inner tubularmember 107, and a mechanism for rotating and for translationally movinginner tubular member 107 relative to outer tubular member 106, device261 does not include structure corresponding to inner tubular member 107(nor does it include a corresponding mechanism for rotating and fortranslationally moving such an inner tubular member). Instead, device261 comprises a tubular member 263. Tubular member 263, in turn,comprises an opening 265 having one or more cutting edges 267. In use, apolyp or similar tissue may be drawn, by suction, into tubular member263 through window 265. The tissue may then be cut along one or more ofedges 267 by manually moving device 261 and tubular member 263 in thedirection opposite to the direction of suction.

FIGS. 9(a) through 9(c) illustrate a still further embodiment of atissue cutting device for use in system 11, the tissue cutting devicebeing represented generally by reference numeral 271. Device 271 issimilar in most respects to device 41, the principal difference betweenthe two devices being that, whereas device 41 comprises an outer tubularmember 106 and an inner tubular member 107, device 271 comprises anouter tubular member 273 and an inner tubular member 275.

Outer tubular member 273 is similar in many respects to outer tubularmember 106 (or to outer tubular member 181 of device 180), the principaldifference between the two outer tubular members being that, whereasouter tubular member 106 comprises a single window 119, outer tubularmember 273 is shaped to include four transverse windows 277 evenlyspaced around its circumference. Inner tubular member 275 is similar inmany respects to inner tubular member 107, the principal differencebetween the two inner tubular members being that, whereas inner tubularmember 107 comprises a beveled distal end 122, inner tubular member 275comprises a distal end 281 shaped to include a blade 283. In use, withdevice 271 inserted into a patient and with suction applied, a polyp orother tissue may be drawn into the interior of outer tubular member 273through one or more of windows 277. As inner tubular member 275 rotateswithin outer tubular member 273, the tissue that has been drawn intoouter tubular member 273 is severed by blade 283.

FIG. 10 is a fragmentary top view of a seventh alternate embodiment of atissue cutting device for use in system 11, represented generally byreference numeral 301. Device 301 is similar in most respects to device41. One difference between the two devices is that, whereas device 41comprises outer tubular member 106 and inner tubular member 107, device301 comprises an outer tubular member 303 and an inner tubular member305. Outer tubular member 303 is similar in most respects to outertubular member 106 (or to outer tubular member 181 of device 180), theprincipal difference between the respective outer tubular members beingthat, whereas outer tubular member 106 comprises a window 119, outertubular member 303 comprises a window 307. Window 307 has a generallytear-drop profile, with window 307 having a cutting edge 309 at itsnarrow distal end 311. Inner tubular member 305 is similar in mostrespects to inner tubular member 107, the principal difference betweenthe two inner tubular members being that, whereas inner tubular member107 comprises a sharpened distal end 122, inner tubular member 305comprises a blunt distal end 313.

In use, inner tubular member 305 oscillates translationally relative toouter tubular member 303, and a polyp or similar tissue may be drawn, bysuction, into the interior of outer tubular member 303 through window307 when inner tubular member 305 is moved sufficiently proximallyrelative to window 307. The tissue may then be cut as inner tubularmember 305 moves distally and pushes the drawn tissue against cuttingedge 309 of outer tubular member 303. The severed tissue may then beremoved, by suction, through the hollow interior of inner tubular member305. As can be appreciated, since rotational movement of inner tubularmember 305 may not be desired, structure corresponding to distal portion102-2 and spur gear 81 of device 41 may be omitted from device 301.

FIG. 11 is a fragmentary side view of an eighth alternate embodiment ofa tissue cutting device for use in system 11, the eighth alternateembodiment being represented generally by reference numeral 351. Device351 is similar in most respects to device 41. One difference between thetwo devices is that, whereas device 41 comprises outer tubular member106 and inner tubular member 107, device 351 comprises an outer tubularmember 353 and an inner tubular member 355. Outer tubular member 353 issimilar in most respects to outer tubular member 106 (or to outertubular member 181 of device 180), the principal difference between therespective outer tubular members being that, whereas outer tubularmember 106 comprises a window 119, outer tubular member 353 comprises awindow 357. Window 357 differs from window 119 in that window 357 has adistal end 359 that bends back proximally and is well-suited forcapturing tissue. Inner tubular member 355 is similar in most respectsto inner tubular member 107, the principal difference between the twoinner tubular members being that, whereas inner tubular member 107comprises a sharpened distal end 122, inner tubular member 355 comprisesa sharpened distal end 363.

In use, inner tubular member 355 oscillates translationally relative toouter tubular member 353, and a polyp or similar tissue may be drawn, bysuction, into the interior of outer tubular member 353 through window357 when inner tubular member 355 is moved sufficiently proximallyrelative to window 357. The tissue may then be cut as inner tubularmember 355 moves distally and the drawn tissue is trapped between distalend 363 of inner tubular member 355 and distal end 359 of window 357.The severed tissue may then be removed, by suction, through the hollowinterior of inner tubular member 355. As can be appreciated, sincerotational movement of inner tubular member 355 may not be desired,structure corresponding to distal portion 102-2 and spur gear 81 ofdevice 41 may be omitted from device 351.

FIG. 12 is a fragmentary side view of a ninth alternate embodiment of atissue cutting device for use in system 11, the ninth alternateembodiment being represented generally by reference numeral 371. Device371 is similar in most respects to device 351, the principal differencebetween the two devices being that, whereas device 351 comprises awindow 357 having a distal end 359, device 371 comprises a window 373having a distal end 375. Device 371 may be used in the same manner asdevice 351.

FIG. 13 is a fragmentary side view of a tenth alternate embodiment of atissue cutting device for use in system 11, the tenth alternateembodiment being represented generally by reference numeral 391. Device391 is similar in most respects to device 41. One difference between thetwo devices is that, whereas device 41 comprises an outer tubular member106 and an inner tubular member 107, device 391 comprises an outertubular member 393 and an inner tubular member 395 (inner tubular member395 shown separately in FIG. 14, but not to-scale). Outer tubular member393 is similar in most respects to outer tubular member 106, theprincipal difference between the two outer tubular members being that,whereas outer tubular member 106 may be made of plastic, outer tubularmember 393 may be made of plastic, stainless steel, or another suitablematerial. Inner tubular member 395 is similar in most respects to innertubular member 107, the principal difference between the two innertubular members being that, whereas inner tubular member 107 may be madeof 300-series stainless steel and may have a uniform inner diameter overits entire length (or, alternatively, may have a distal portion having auniform first diameter and a proximal portion having a uniform seconddiameter, the second diameter being slightly greater than the firstdiameter), inner tubular member 395 may be made of a molded plastic,such as an injection molded liquid crystal polymer, and is conicallyshaped to taper from a more narrow distal end 397 to a wider proximalend 399. The broadening of inner tubular member 395, particularly thewidening of its inner diameter, moving from distal end 397 to proximalend 399 may reduce the risk that inner tubular member 395 may becomeclogged with solid matter. The taper may be on the order ofapproximately 0.1 inch in diameter over a length of approximately 12inches.

FIG. 15 depicts a second embodiment of a tissue removal systemconstructed according to the teachings of the disclosure, the tissueremoval system being represented generally by reference numeral 411.System 411 is similar in many respects to system 11, the principaldifference between the two systems being that, whereas system 11comprises specimen container 141 and vacuum source 143, system 411comprises a syringe 413. System 411 may be used in much the same manneras system 11, except that, when one wishes to apply suction, one usessyringe 413. In this manner, one may control when suction is beingapplied so as to limit the amount of distending fluid that is suctionedwhen device 41 is not being used to cut tissue.

FIG. 16 depicts a third embodiment of a tissue removal systemconstructed according to the teachings of the disclosure, the tissueremoval system being represented generally by reference numeral 451.System 451 is similar in many respects to system 11. One differencebetween the two systems is that, whereas system 11 comprises device 41and a motorized mechanism for powering device 41 (which motorizedmechanism includes unit 151 and foot switch 153), system 451 comprises ahand-powered device 453. Another difference between system 451 andsystem 11 is that, whereas actuation of vacuum source 143 is coupled toactuation of unit 151, system 451 comprises a vacuum source 454 that iscontinuously being operated. A “continuously operated vacuum source” isa vacuum source that is applying suction for a period of time thatencompasses and exceeds the period of time during which cutting occurs.Consequently, as will be seen below, device 453 may be designed so thatsuction from source 454 is applied to a patient only when device 453 isactively being used to cut tissue.

Device 453 is shown in greater detail in FIG. 17, and includes agun-shaped housing 455 shaped to include a handle portion 457 and abarrel portion 459. Housing 455 is formed from a pair of matchinghousing halves 461, the right housing half not being shown in FIG. 17 toreveal the interior of housing 455. Device 453 also comprises a trigger463, which is pivotally mounted to housing 455 about a pivot pin 465.Trigger 463 is shaped to include a first end 463-1 positioned inside ofhousing 455 and a second end 463-2 positioned outside of housing 455.First end 463-1 is rounded in profile and shaped to include a set ofgear teeth 467 positioned along a portion of its circumference.

Device 453 further comprises a reversing gear 469 pivotally mounted tohousing 455 about a pivot pin 471. Gear 471 includes a first set ofteeth 473 engageable with teeth 467 on trigger 463.

Device 453 further comprises a carriage 475 slidably mounted withinhousing 455. Carriage 475 is shaped to include a set of teeth 477engageable with a second set of teeth 479 provided on gear 469. In thismanner, the squeezing of trigger 463 causes carriage 475 to be movedback a short distance in the direction of the proximal end 459-1 ofbarrel portion 459. A spring 481 having a first end 481-1 fixed tocarriage 475 and a second end 481-2 fixed to the distal end 459-2 ofbarrel portion 459 is used to bias carriage 475 in the direction ofdistal end 459-2.

Device 453 further comprises an outer tubular member 483 fixedly mountedto housing 455 and extending distally from distal end 459-2 of barrelportion 459. Outer tubular member 483 is similar to outer tubular member106 or to outer tubular member 181 and includes a window 485 throughwhich a polyp or similar tissue may pass to the interior of member 483.

Device 453 further comprises an inner tubular member 487. Inner tubularmember 487 is shaped to include a proximal end 487-1 and a distal end487-2. Proximal end 487-1 is disposed within a vacuum connector 489fixedly mounted at proximal end 459-1 of barrel portion 459. Connector489 has a barbed proximal end 489-1 adapted for insertion into thedistal end of vacuum tube 130. An O-ring 491 is inserted around proximalend 487-1 to provide a vacuum seal around inner tubular member 487.Distal end 487-2 of inner tubular member 487 is disposed within outertubular member 483. An intermediate portion of inner tubular member 487is inserted through and fixedly coupled to carriage 475. In this manner,as carriage 475 moves back and forth in barrel portion 459, innertubular member 487 moves back and forth correspondingly. It should benoted that, unlike, for example, inner tubular member 107, inner tubularmember 487 does not rotate, but rather, only moves translationally inthe manner discussed above.

In use, vacuum connector 489 may be connected to vacuum source 454, andouter tubular member 483 may be inserted into the patient (either viaaccess device 13 or otherwise) and positioned so that window 485 isaligned with a polyp or similar tissue. Next, trigger 463 may besqueezed towards handle portion 457. As trigger 463 is initially drawntowards handle portion 457, the squeezing of trigger 463 causes gear 469to rotate due to the engagement of teeth 467 with teeth 473. This, inturn, causes carriage 475 to be moved backwards a short distance towardsproximal end 459-1 as a result of the engagement of teeth 477 with teeth479. This movement of carriage 475, in turn, causes inner tubular member487 to be moved proximally relative to outer tubular member 483,permitting the polyp or like tissue to be drawn by suction throughwindow 485 and into the interior of outer tubular member 483. However,due to the number and placement of teeth 467 and 473 on trigger 463 andgear 469, respectively, as trigger 463 continues to be squeezed towardshandle portion 457, teeth 467 are moved past teeth 473, causing gear 469to become disengaged from trigger 463. This disengagement of gear 469from trigger 463 allows spring 481 to pull carriage 475 back distally toits initial position, thereby causing the tissue extending throughwindow 485 to be severed. The distal movement of carriage 475simultaneously causes gear 469 to be rotated back to its initial angularposition.

As can be seen, one advantageous feature of device 453 is that, eventhough vacuum source 454 is continuously being operated, no suction isapplied to the contents of the uterus through device 453 unless trigger463 is being operated since window 485 is kept closed by inner tubularmember 487, except while trigger 463 is being actuated. When trigger 463is no longer being actuated and returns to its inactive position, innertubular member 487 returns to its most distal position, where itcompletely seals off window 485. In other words, device 453 does notrequire that any active steps be taken in order to close window 485after operation of trigger 463 as the release of trigger 463 causesinner tubular member 487 to return to a position in which it closeswindow 485.

FIG. 18 is a side view of a first alternate embodiment of a tissuecutting device for use in system 451, the tissue cutting device beingrepresented generally by reference numeral 501. Device 501 comprises agun-shaped housing 503, which includes a handle portion 505 and a barrelportion 507. Housing 503 is formed from a pair of matching housinghalves 509, the right housing half not shown in FIG. 18 to therebyreveal the interior of housing 503.

Device 501 also comprises a trigger 511, which is pivotally mounted tohousing 503 about a pivot pin 513. Trigger 511 is shaped to include afirst end 515-1 positioned inside of housing 503 and a second end 515-2positioned outside of housing 503. First end 515-1 is rounded in profileand shaped to include a helical gear 517 (see also FIG. 18(a)) extendingalong much of its circumference. A spring 516 connected at one end to aproximal end 507-1 of barrel portion 507 and at the opposite end tofirst end 515-1 of trigger 511 is used to bias second end 515-2 oftrigger 511 away from handle portion 509.

Device 501 further comprises an outer tubular member 541 fixedly mountedto housing 503 and extending distally from a distal end 507-2 of barrelportion 507. Outer tubular member 541 is similar to outer tubular member106 or to outer tubular member 181, and includes a window 543 throughwhich a polyp or similar tissue may pass to the interior of member 541.

Device 501 further comprises an inner tubular member 545, which includesa proximal end 545-1 and a distal end 545-2. Proximal end 545-1 isdisposed within a vacuum connector 547 fixedly mounted at proximal end507-1 of barrel portion 507. Connector 547 has a barbed proximal end547-1 adapted for insertion into vacuum tube 130. An O-ring 549 isinserted around proximal end 545-1 of inner tubular member 545 toprovide a vacuum seal around inner tubular member 545. Distal end 545-2of inner tubular member 545 is disposed within outer tubular member 541.A transverse opening 546 is provided in inner tubular member 545proximate to distal end 545-2. Opening 546 is appropriately positionedon inner tubular member 545 so that, by appropriately rotating innertubular member 545, opening 546 becomes aligned with opening 543 ofouter tubular member 541.

Device 501 further comprises a helical gear 551 inserted over andfixedly coupled to an intermediate portion of inner tubular member 545,helical gear 551 being engaged with helical gear 517. Helical gear 551and helical gear 517 are appropriately dimensioned so that one triggerstroke results in one complete rotation of inner tubular member 545. Itshould be noted that, unlike, for example, inner tubular member 107,inner tubular member 545 does not move translationally, but rather, onlyrotates.

In use, vacuum connector 547 is connected to vacuum source 454, andouter tubular member 541 is inserted into the patient (either via accessdevice 13 or otherwise) and positioned so that window 543 is alignedwith a polyp or similar targeted tissue. Next, trigger 511 is squeezedtowards handle portion 505. As trigger 511 is drawn towards handleportion 505, gear 517 on trigger 511 causes gear 551 to turn which, inturn, causes inner tubular member 545 to rotate. During a portion of itsrotation, opening 546 in inner tubular member 545 comes into alignmentwith window 543 of outer tubular member 541. During this period in whichopening 546 and window 543 are aligned, suction is able to be applied towindow 543, and a polyp or similar targeted tissue may be drawn throughboth window 543 and opening 546. Then, as inner tubular member 545continues to rotate, opening 546 moves out of angular alignment withwindow 543, causing the polyp or like tissue to be severed. Thereafter,as trigger 511 is released, inner tubular member 545 rotates back to itsinitial angular position.

One advantageous feature of device 501 is that, even if vacuum source454 is continuously being operated, no suction is applied to thecontents of the uterus through device 501, except during a short portionof the trigger stroke in which window 543 and opening 546 are alignedwith one another. This is because, before trigger 511 is actuated andafter trigger 511 returns to its inactive position, opening 546 is notaligned with window 543. Consequently, device 501 does not require thatany active steps be taken in order to close window 543 after operationof trigger 511 as the release of trigger 511 causes inner tubular member545 to return to a position in which it closes window 543.

FIG. 19 is a side view of a second alternate embodiment of a tissuecutting device for use in system 451, the tissue cutting device beingrepresented generally by reference numeral 601. Device 601 comprises agun-shaped housing 603 having a handle portion 605 and a barrel portion607. Housing 603 is formed from a pair of matching housing halves 609,the right housing half not being shown in FIG. 19 to reveal the interiorof housing 603.

Device 601 also comprises a trigger 611, which is pivotally mounted tohousing 603 about a pivot pin 613. Trigger 611 includes a first end615-1 positioned inside of housing 603 and a second end 615-2 positionedoutside of housing 603. First end 615-1 is wedge-shaped and includes amulti-toothed gear 614 arranged along its wide end. A spring 616connected at one end to a proximal end 607-1 of barrel portion 607 andat the opposite end to first end 615-1 of trigger 611 is used to biassecond end 615-2 of trigger 611 away from handle portion 609.

Device 601 further comprises an outer tubular member 641 fixedly mountedto housing 603 and extending distally from a distal end 607-2 of barrelportion 607. Outer tubular member 641 is similar to outer tubular member106 or to outer tubular member 181, and includes a window 643 throughwhich a polyp or similar tissue may pass to the interior of outertubular member 641.

Device 601 further comprises an inner tubular member 645. Inner tubularmember 645 is similar in shape to inner tubular member 487 and includesa proximal end and a distal end. The proximal end of inner tubularmember 645 is disposed within a vacuum connector 647 fixedly mounted atproximal end 607-1 of barrel portion 607. Connector 647 has a barbedproximal end 647-1 adapted for insertion into vacuum tube 130. An O-ring(not shown) may be inserted around the proximal end of inner tubularmember 645 within connector 647 to provide a vacuum seal around innertubular member 645. The distal end of inner tubular member 645 isdisposed within outer tubular member 641.

Device 601 further comprises a coupling member 651 inserted over innertubular member 645 and fixedly coupled thereto for translational androtation movement. Coupling member 651 comprises a proximal portion 653and a distal portion 655. Proximal portion 653 comprises an elongatedspur gear engaged with gear 614 in such a way that, as trigger 611 ispivoted, gear 614 rotates, thereby causing inner tubular member 645 torotate. Distal portion 655 comprises a wobble member that causescoupling member 651 and inner tubular member 645 to move proximally astrigger 611 is squeezed and to move distally as trigger 611 is released.

In use, vacuum connector 647 is connected to vacuum source 454, andouter tubular member 641 is inserted into the patient (either via accessdevice 13 or otherwise) and positioned so that window 643 is alignedwith a polyp or similar targeted tissue. Next, trigger 611 is squeezedtowards handle portion 605. As trigger 611 is drawn towards handleportion 605, gear 614 on trigger 611 causes proximal portion 653 ofcoupling member 651 to turn which, in turn, causes inner tubular member645 to rotate. At the same time that inner tubular member 645 isrotating, distal portion 655 of coupling member 651 causes inner tubularmember 645 to be moved proximally in front of window 643, therebyallowing suction to be applied to window 643 and causing the polyp orsimilar targeted tissue to be drawn through window 643 into the interiorof outer tubular member 641. Thereafter, as trigger 611 is released,inner tubular member 645 is caused to rotate back to its initial angularposition and is caused to move distally back to it is initialtranslational position. As inner tubular member 645 moves distallyacross window 643, the tissue extending through window 643 is severed bythe moving inner tubular member 645.

One advantageous feature of device 601 is that, even if vacuum source454 is continuously being operated, no suction is applied to thecontents of the uterus through device 601, except during a portion ofthe trigger stroke in which the distal end of inner tubular member 645is moved proximally sufficiently to open window 643. This is because,before trigger 611 is actuated and after trigger 611 returns to itsinactive position, window 643 is closed off by inner tubular member 645.Consequently, device 601 does not require that any active steps be takenin order to close window 643 after operation of trigger 611 as therelease of trigger 611 causes inner tubular member 645 to return to aposition in which it closes window 643.

FIG. 20 depicts a fourth embodiment of a tissue removal systemconstructed according to the teachings of the disclosure, the tissueremoval system being represented generally by reference numeral 701.System 701 is similar in many respects to system 11. One differencebetween the two systems is that, whereas motor unit 151 and vacuumsource 143 of system 11 are coupled together via cable 165 so as to beeither switched on together or switched off together, motor unit 151 andvacuum source 143 are not coupled together. Instead, in system 701,vacuum source 143 is continuously operating (unless system 701 iscompletely shut down) whereas motor unit 151 is switched on and offusing a foot switch 153. Another difference between system 11 and system701 is that, whereas system 11 comprises tissue cutting device 41,system 701 comprises a tissue cutting device 703. As will hereinafter bedescribed, device 703 is designed so that, when foot switch 153 isdepressed, suction from vacuum source 143 is applied to the patientthrough a resection window 705 in an outer tubular member 707 in device703 and, thereafter, when foot switch 153 is no longer depressed, device701 no longer permits suction from vacuum source 143 to be applied tothe patient through window 705 due to a passive, entirely mechanicalarrangement for moving an inner tubular member 709 in such a way as toclose window 705.

Referring now to FIGS. 21(a) through 21(g), there are shown variousviews of device 703, certain components of device 703, such as thedevice housing 710 (which is shown in FIG. 20), not being shown in FIGS.21(a) through 21(g) for clarity, and other components of device 703being shown in some but not others of FIGS. 21(a) through 21(g).

Device 703 comprises a rotatable drive shaft 711. Drive shaft 711includes at its proximal end a drive socket 713 adapted to bemechanically coupled to an external drive shaft (not shown). A washer715 is fixedly mounted or integrally formed on drive shaft 711 at anintermediate location thereon.

Device 703 further comprises a cone clutch/bevel gear 721, a cone spring723, and a cone clutch/spur gear 725, all three components being looselyinserted over, i.e., floating on, drive shaft 711. The proximal end ofcone clutch/bevel gear 721 abuts the distal end of washer 715. Aproximal end 723-1 of cone clutch spring 723 sits within a groove 727provided in the distal end of cone clutch/bevel gear 721. A distal end723-2 of cone clutch spring 723 sits within a groove 729 provided in theproximal end of cone clutch/spur gear 725. The distal end of coneclutch/bevel gear 721 and the proximal end of cone clutch/spur gear 725are complementarily shaped to selectively permit mating engagement withone another. The distal end of cone clutch/spur gear 725 is shaped toinclude a cam 731.

Device 703 further comprises a cap 733 inserted over and fixedly mountedto distal end 711-1 of shaft 711 for rotation therewith. Cap 733comprises a proximal portion 735 and a distal portion 737. Proximalportion 735 is shaped to include a cam 739 engageable in the mannerhereinafter described with cam 731 of cone clutch/spur gear 725. Distalportion 737 comprises a dome-shaped member adapted to rotatably sitwithin a bearing 741 fixed to the inside of housing 710.

Device 703 further comprises a pinion gear 745 inserted over and fixedlymounted to inner tubular member 709 at an intermediate location thereon.Pinion gear 745 is engaged with and coupled for rotation to teeth 746 ofcone clutch/spur gear 725.

Device 703 further comprises a driver 747 inserted over and fixedlymounted to inner tubular member 709, driver 747 abutting the proximalend of pinion gear 745. Driver 747 includes a mounting post 749, whichis used to receive one end of a bell crank 751. The opposite end of bellcrank 751 is mounted on a post 753 formed on a bevel gear 755, bevelgear 755 being engaged with teeth 756 on cone clutch/bevel gear 721.

Device 703 further comprises a spring 761 inserted over inner tubularmember 709. Spring 761 comprises a proximal end 761-1 fixed to a cap 763on the inside of housing 710 and a distal end 761-2 fixed to theproximal end of drive 747.

The manner in which device 703 may be operated is illustrated in FIGS.21(e) through 21(g). As seen best in FIG. 21(e), prior to actuation ofdevice 703, cone clutch/spur gear 725 and cap 733 are angularlypositioned relative to one another so that cam 731 of cone clutch/spurgear 725 is aligned with cam 739 of cap 733. In addition, teeth 756 ofcone clutch/bevel gear 721 are engaged with bevel gear 755, and teeth746 of cone clutch/spur gear 725 are engaged with pinion gear 745.Notwithstanding the above, there is no movement of the aforementionedcomponents prior to actuation of device 703.

With the depression of foot switch 153, the external drive shaft that iscoupled to motor unit 151 begins to rotate. Because this external driveshaft is rotationally coupled to drive socket 713, the rotation of theexternal drive shaft causes drive socket 713 and drive shaft 711 torotate. As drive shaft 711 begins to rotate, cap 733, which is fixed todistal end 711-1 of drive shaft 711, also begins to rotate. By contrast,cone clutch/spur gear 725 is not fixedly coupled for rotation to driveshaft 711, and as cap 733 initially begins to rotate, cone clutch/spurgear 725 does not rotate. The rotation of cap 733 relative to coneclutch/spur gear 725 causes cam 739 to begin to slide along cam 731,causing cap 733 to push cone clutch/spur gear 725 and spring 723proximally towards cone clutch/bevel gear 721. This proximal pushing ofcone clutch/spur gear 725 and spring 723 towards cone clutch/bevel gear721 continues until a contact point 740 at the end of cam 739 engages acontact point 732 at the end of cam 731. With contact points 740 and 732thus engaged with one another, as is shown in FIG. 21(f), coneclutch/spur gear 725 becomes engaged with and coupled for rotation tocap 733. Moreover, the above-described proximal pushing of coneclutch/spur gear 725 towards cone clutch/bevel gear 721 results in coneclutch/spur gear 725 engaging cone clutch/bevel gear 721 such that coneclutch/bevel gear 721 is coupled for rotation to cone clutch/spur gear725. Consequently, continued rotation of drive shaft 711 results in thesimultaneous rotation of cap 733, cone clutch/spur gear 725 and coneclutch/bevel gear 721. As cone clutch/spur gear 725 rotates, pinion gear745, which is engaged with cone clutch/spur gear 725, also rotates. Thisrotation of pinion gear 745, in turn, causes inner member 709 to rotate.At the same time, as cone clutch/bevel gear 721 rotates, bevel gear 755,which is engaged with cone clutch/bevel gear 721, also rotates. Thisrotation of bevel gear 755, in turn, causes bell crank 751 to movedriver 747 back and forth in an oscillating fashion, with each rotationof bevel gear 755 corresponding to one back and forth cycle of driver747. Because driver 747 is coupled for translational movement to innermember 709, proximal movement of driver 747 causes inner member 709 toretract relative to outer member 707, thereby opening resection window705 (see FIG. 21(g)). Similarly, distal movement of driver 747 causesinner member 709 to return to its distal position within outer member709, closing resection window 705 and cutting any tissue extendingthrough window 705.

When it is desired to turn device 703 off, foot switch 153 is no longerdepressed. This causes the external drive shaft to stop rotating, which,in turn, causes shaft 711 to stop rotating. Because cap 733 is fixed toshaft 711 for rotation, the cessation of rotation of shaft 711 causes acorresponding cessation of rotation of cap 733. Due to inertia, coneclutch/spur gear 725 does not cease rotating as quickly as does cap 733,and, as a result, cone clutch/spur gear 725 rotates relative to cap 733,causing cams 731 and 739 once again to come into in alignment with oneanother. The alignment of cams 731 and 739 with one another, in turn,causes spring 723 to open up and decouples the rotation of coneclutch/bevel gear 721 from cone clutch/spur gear 725. As can beappreciated, with the stoppage of rotation of cone clutch/spur gear 725,pinion gear 745 stops rotating and, thus, so does inner member 709. Inaddition, with the stoppage of rotation of cone clutch/bevel gear 721,bevel gear 755 stops rotating and driver 747 stops moving back andforth. If, when bevel gear 755 stops rotating, driver 747 and innermember 709 are positioned proximally, as in FIG. 21(g), spring 761provides a return force sufficient to return driver 747 and inner member709 to their respective distal positions. In this manner, device 703assures that resection window 705 is not open when device 703 is notbeing used to cut tissue.

Referring now to FIGS. 22(a) through 22(d), there are shown variousviews of a first alternate embodiment of a tissue cutting device for usein system 701, the tissue cutting device being represented generally byreference numeral 801. Device 801, which is similar in certain respectsto device 41, differs notably from device 41 in that device 801 includesa mechanical arrangement for keeping suction from being applied toresection window 119 of outer tubular member 106 when device 801 is notbeing used to cut tissue. Accordingly, whereas device 41 includes innertubular member 107, device 801 instead includes a proximal inner tubularmember 803, a distal inner tubular member 805, and a valved connector807.

Connector 807 comprises a housing 809. Housing 809, in turn, comprises atop piece 811 and a bottom piece 813. Top piece 811 and bottom piece 813are suitably joined together to define a hollow cavity 815, a proximalend 817, and a distal end 819. Member 803 is inserted into proximal end817 of housing 809 and fixed thereto by suitable means, and member 805is inserted into distal end 819 of housing 809 and fixed thereto bysuitable means.

Connector 807 further comprises a clip 821. Clip 821 is a one-piecemember which includes a pair of parallel side arms 823-1 and 823-2 and atransverse arm 825, transverse arm 825 interconnecting side arms 823-1and 823-2. Side arm 823-1 is shaped to include an enlarged disc-shapedmember 824-1 at an end distal to transverse arm 825, and side arm 823-2is shaped to include an enlarged disc-shaped member 824-2 at an enddistal to transverse arm 825. Side arms 823-1 and 823-2 are positionedoutside of housing 809, with transverse arm 825 extending transverselythrough housing 809 using recesses 827 provided in top piece 811 andcomplementary recesses 829 provided in bottom piece 813. Transverse arm825 is shaped to include a door 826 extending perpendicularly therefrom,door 826 being dimensioned to selectively block the flow of fluidsthrough housing 809 in the manner described below.

Connector 807 further comprises a coil spring 831, which has a first end831-1 fixed to a mounting post 833 extending from arm 823-1, and asecond end 831-2 fixed to housing 809. Spring 831 is used to bias clip821 so that, when device 801 is in its rest state, i.e., device 801 isnot being used to cut tissue, clip 821 is positioned so that door 826blocks the flow of fluids through housing 809 (see FIG. 22(c)). Bycontrast, when device 801 is used to cut tissue, proximal tubular member803 is caused to rotate, and, in turn, housing 809, which ismechanically coupled to member 803, is caused to rotate. This rotationof housing 809 effectively creates a centrifugal force that causes arms823-1 and 823-2 to overcome the bias of spring 831 and to swing from anorientation generally parallel to the longitudinal axis of housing 809to an orientation generally perpendicular to the longitudinal axis ofhousing 809, thereby resulting in door 826 being pivoted upwardlytowards top piece 811 of housing 809 (see FIG. 22(d)). With door 826thus pivoted, fluid is permitted to flow through housing 809.Thereafter, when the rotation of proximal tubular member 803 stops andthere is no longer any force overcoming that provided by spring 831,spring 831 causes clip 821 to be pivoted back to its originalorientation, wherein door 826 blocks the flow of fluid through housing809. Therefore, as can be seen, device 801 permits suction to be appliedto distal member 805 only when device 801 is being used to cut tissue.

Referring now to FIGS. 23(a) through 23(f), there are shown variousviews of a second alternate embodiment of a tissue cutting device foruse in system 701, the tissue cutting device being represented generallyby reference numeral 851. Device 851 is similar in many respects todevice 801, the principal difference between the two devices being that,whereas device 801 comprises valved connector 807, device 851 comprisesa valved connector 857.

Connector 857 comprises a tubular housing 859 shaped to include a hollowcavity 865, a proximal end 867, and a distal end 869. Member 803 isinserted into proximal end 867 of housing 859 and fixed thereto bysuitable means, and member 805 is inserted into distal end 869 ofhousing 859 and fixed thereto by suitable means. Housing 859 alsocomprises a transverse opening 870 provided in a top wall 871 of housing859 midway between proximal end 867 and distal end 869, and furthercomprises a pair of transverse slots 872-1 and 872-2 provided in topwall 871 on proximal and distal sides, respectively, of opening 870.

Connector 857 further comprises a slide 881. Slide 881 may be aone-piece member shaped to include an elongated post 883 having a squareflange 884 at one end of post 883 and a disc-shaped knob 887 at anopposite end of post 883. Slide 881 also includes a paddle 889 extendingdownwardly from the flange 884. Paddle 889 is appropriately dimensionedto be inserted through opening 870 and to selectively block the flow offluids through housing 859 in the manner described below.

Connector 857 further comprises a support bracket 891. Bracket 891includes a pair of legs 893-1 and 893-2 and a bridge 895, bridge 895interconnecting legs 893-1 and 893-2 at their respective top ends. Thebottom ends of legs 893-1 and 893-2 are appropriately dimensioned to beinserted into and securely retained within openings 872-1 and 872-2,respectively. Bridge 895 includes a transverse slot 897. Legs 893-1 and893-2 and slot 897 are appropriately dimensioned for post 883 to extendtherethrough, with knob 887 being retained by the top surface of bridge895.

Connector 857 further comprises a coil spring 899. Coil spring 899 isinserted coaxially around post 883 of slide 881, with a first end 899-1of coil spring 899 seated on flange 884 and a second end 899-2 of coilspring 899 abutting the bottom surface of bridge 895.

When device 851 is in its rest state, i.e., device 851 is not being usedto cut tissue, slide 881 is biased by spring 899 downwardly into cavity865 so that paddle 889 blocks the flow of fluids through housing 859(see FIGS. 23(c) and 23(e)). By contrast, when device 851 is used to cuttissue, proximal tubular member 803 is caused to rotate and, in turn,housing 859, which is mechanically coupled to member 803 is also causedto rotate. This rotation of housing 859 effectively creates acentrifugal force that causes slide 881 to overcome the bias of spring899 and to slide radially outwardly away from cavity 865, therebyallowing fluids to flow between proximal end 867 and distal end 869 ofhousing 859 (see FIGS. 23(d) and 23(f)). Thereafter, when the rotationof proximal tubular member 803 stops and there is no longer any forceovercoming that provided by spring 899, spring 899 forces slide 881downwardly such that paddle 889 once again blocks the flow of fluidthrough housing 859. Therefore, as can be seen, device 851 permitssuction to be applied to distal member 805 only when device 851 is beingused to cut tissue.

Referring now to FIGS. 24(a) through 24(d), there are shown variousviews of a third alternate embodiment of a tissue cutting device for usein system 701, the tissue cutting device being represented generally byreference numeral 901. Device 901 is similar in many respects to device801, the principal difference between the two devices being that,whereas device 801 comprises valved connector 807, device 901 comprisesa valved connector 907.

Connector 907 comprises a housing 909. Housing 909, in turn, comprises atop piece 911 and a bottom piece 913. Top piece 911 and bottom piece 913are suitably joined together to define a hollow cavity 915, a proximalend 917, and a distal end 919. Top piece 911 includes a vent 912.

Member 803 is inserted into proximal end 917 of housing 909 and fixedthereto by suitable means, and member 805 is inserted into distal end919 of housing 909 and fixed thereto by suitable means.

Connector 907 further comprises a clip 921. Clip 921 may be a one-piecemember shaped to include a pair of parallel side arms 923-1 and 923-2and a transverse arm 925, transverse arm 925 interconnecting side arms923-1 and 923-2. Side arm 923-1 includes an enlarged disc-shaped member924-1 at an end distal to transverse arm 925, and side arm 923-2includes an enlarged disc-shaped member 924-2 at an end distal totransverse arm 925. Side arms 923-1 and 923-2 are positioned outside ofhousing 909, with transverse arm 925 extending transversely throughhousing 909 using recesses 927 provided in top piece 911 andcomplementary recesses 929 provided in bottom piece 913. Transverse arm925 is shaped to include a door 926 extending perpendicularly therefrom,door 926 being dimensioned to selectively cover vent 912 in the mannerdescribed below.

Connector 907 further comprises a coil spring 931 having a first end931-1 fixed to a mounting post 933 extending from arm 923-1, and asecond end 931-2 fixed to a post 932 on housing 909. Spring 931 is usedto bias clip 921 so that, when device 901 is in its rest state, i.e.,device 901 is not being used to cut tissue, clip 921 is positioned sothat door 926 does not cover vent 912 (see FIG. 24(c)).

Connector 907 further comprises a clip 941. Clip 941 may be a one-piecemember shaped to include a pair of parallel side arms 943-1 and 943-2and a transverse arm 945, transverse arm 945 interconnecting side arms943-1 and 943-2. Side arms 943-1 and 943-2 are positioned outside ofhousing 909, with transverse arm 945 extending transversely throughhousing 909 using recesses 947 provided in top piece 911 andcomplementary recesses 949 provided in bottom piece 913. Transverse arm945 is shaped to include a damper 946 extending perpendicularlytherefrom, damper 946 being dimensioned to block the flow of fluidthrough housing 909 in the manner described below.

Connector 907 further comprises a coil spring 951 having a first end951-1 fixed to a mounting post 953 extending from arm 923-1, and asecond end 951-2 fixed to a post 954 on housing 909. Spring 951 is usedto bias clip 941 so that, when device 901 is in its rest state, i.e.,device 901 is not being used to cut tissue, clip 941 is positioned sothat damper 946 blocks the flow of fluid through housing 900 (see FIG.24(c)).

When device 901 is not being used to cut tissue, door 926 does not covervent 912, and damper 946 blocks the flow of fluid through housing 900(see FIG. 24(c)). As a result, suction applied to member 803 results inair being drawn into housing 909 through vent 912, and, consequently, nosuction is applied to member 805. By contrast, when device 901 is usedto cut tissue, proximal tubular member 803 is caused to rotate, and, inturn, housing 909, which is mechanically coupled to member 803, iscaused to rotate. This rotation of housing 909 effectively creates acentrifugal force that causes arms 923-1 and 923-2 to overcome the biasof spring 931 and to swing from an orientation generally parallel to thelongitudinal axis of housing 909 to an orientation generallyperpendicular to the longitudinal axis of housing 909, thereby resultingin door 926 being pivoted upwardly to cover vent 912. With vent 912covered, the continued application of suction to member 803 overcomesthe bias of spring 951 and causes damper 946 to be pivoted upwardly,thereby allowing fluid to flow from the distal end 919 of housing 909 tothe proximal end 917 of housing 909 (see FIG. 24(d)). Thereafter, whenthe rotation of proximal tubular member 803 stops and there is no longerany force overcoming that provided by spring 931, spring 931 causes clip921 to be pivoted back to its original orientation away from coveringvent 912. With vent 912 once again uncovered, the suction applied tomember 803 causes air to be drawn in through vent 912, therebyminimizing the suction applied to damper 946, which then, due to spring951, pivots back to its original position blocking the flow of fluidthrough housing 909. Therefore, as can be seen, device 901 permitssuction to be applied to distal member 805 only when device 901 is beingused to cut tissue.

Referring now to FIGS. 25(a) through 25(d), there are shown variousviews of a fourth alternate embodiment of a tissue cutting device foruse in system 701, the tissue cutting device being represented generallyby reference numeral 971. Device 971 is similar in many respects todevice 801, the principal difference between the two devices being that,whereas device 801 comprises valved connector 807, device 971 comprisesa valved connector 977.

Connector 977 comprises a housing 979. Housing 979, in turn, comprises atop piece 981 and a bottom piece 983. Top piece 981 and bottom piece 983are suitably joined together to define a generally tubular proximalportion 984 and a generally tubular distal portion 986, proximal portion984 and distal portion 986 being in fluid communication with oneanother, proximal portion 984 having a greater maximum diameter thandistal portion 986. Proximal portion 984 is shaped to include a proximalend 987, an outwardly tapering proximal wall 988, an inwardly taperingdistal wall 989, and a side wall 990, side wall 990 interconnectingproximal wall 988 and distal wall 989. Three transverse openings 991 areevenly spaced around the circumference of side wall 990. Distal portion986 is shaped to include a distal end 992. Member 803 is inserted intoproximal end 987 of proximal portion 984 of housing 909 and fixedthereto by suitable means, and member 805 is inserted into distal end992 of distal portion 986 of housing 909 and fixed thereto by suitablemeans.

Connector 977 further comprises three balls 993 disposed within proximalportion 984. Balls 993 are appropriately dimensioned to selectivelycover openings 991 in the manner described below. Although not shown,proximal portion 984 may be shaped to include one or more tracks toassure that each ball 993 is aligned with a corresponding opening 991.Also, it should be understood that while connector 977 has beendescribed herein as having three balls 993 and three openings 991,connector 977 may be modified to include a greater or lesser number ofballs 993 and a corresponding number of openings 991. Connector 977further comprises a duckbill valve 995 securely mounted within distalportion 986 of housing 979.

When device 971 is not being used to cut tissue, balls 993 do not coveropenings 991 (see FIG. 25(c)). As a result, suction applied to member803 results in air being drawn into housing 979 through openings 991,and, consequently, no suction is applied to member 805. By contrast,when device 971 is used to cut tissue, proximal tubular member 803 iscaused to rotate, and, in turn, housing 979, which is mechanicallycoupled to member 803, is caused to rotate. This rotation of housing 979effectively creates a centrifugal force that moves balls 993 radiallyoutwardly, where they cover openings 991 (see FIG. 25(d)). With openings991 thus covered, the continued application of suction to member 803opens valve 995 and results in suction being applied to member 805.Thereafter, when the rotation of proximal tubular member 803 stops, andballs 993 are no longer forced radially outwardly against openings 991,thereby leaving openings 991 uncovered, the suction applied to member803 causes air to be drawn in through opening 991. As a result, valve995 is closed once again, and no suction is applied to member 805.Therefore, as can be seen, device 971 permits suction to be applied todistal member 805 only when device 971 is being used to cut tissue.

FIGS. 26(a)-26(c) illustrate still another embodiment of a tissueremoval device 1000. The tissue removal device 1000 in this embodimentis not attached to a motor unit or a vacuum source. Rather, the tissueremoval device 1000 includes manually operated assemblies, described infurther detail below, for creating vacuum and for cutting tissue.

Tissue removal device 1000 is similar in many respects to the tissueremoval devices previously described herein. For example, similar to theother tissue removal devices described herein, tissue removal device1000 includes a housing 1002 having a distal end 1004 and a proximal end1006, an outer tubular member 1008 having a proximal end 1010 coupled tothe distal end 1004 of the housing 1002 and a distal end 1012 having atissue resection window 1014, and an inner tubular member 1016configured for sliding within the outer tubular member 1008. The outertubular member 1008 may be configured for transcervical insertion.Additionally or alternatively, the outer tubular member 1008 isconfigured for insertion through a working channel of an endoscopicinstrument so that the tissue resection window 1014 is positioned in aninterior region of a patient's body. The distal end 1012 of the outertubular member 1008 may be conformable or rigid. The outer tubularmember 1008 may be configured to rotate relative to the housing 1002.The inner tubular member 1016 is hollow, and includes an open distal end1018, an open proximal end 1019, and a lumen extending between the opendistal end 1018 and the open proximal end 1019. The distal end 1018 ofthe inner tubular member 1016 includes a cutting edge for severingtissue projecting into the tissue resection window 1014.

However, whereas the other tissue removal devices described herein areconfigured for being operated while attached to a vacuum source and/or amotor unit, the tissue removal device 1000 is completely manuallyoperated. Thus, the tissue removal device 1000 is “tetherless,” becauseit does not require tubes or cables for connecting the device 1000 to avacuum source and/or a motor unit.

The tissue removal device 1000 comprises an actuator in the form of amanually operated actuator, or trigger 1020 coupled to the housing 1002by a pinned connection 1022. The trigger 1020 includes a first end 1024positioned inside of the housing 1002, and a second end 1026 positionedoutside of the housing 1002. The trigger 1020 is coupled to the housing1002 such that a user may hold the housing 1002 in one hand and actuatethe trigger 1020 by squeezing, thus rotating the trigger 1020 towardsthe housing 1002 about the pivot point 1022. A spring 1023 coupled tothe housing 1002 and the trigger 1020 causes the trigger 1020 to bebiased away from the housing 1002, as shown in FIGS. 26(a)-26(c). Inthis manner, when the trigger 1020 is released after being actuated, thespring 1023 restores the trigger 1020 to its unactuated position awayfrom the housing 1002. It should be understood that the individualcomponents of the device 1000 illustrated in FIGS. 26(a)-26(c) are notnecessarily drawn to scale, and that FIGS. 26(a)-26(c) are provided forillustrating the principles of the disclosed embodiments.

The first end 1024 of the trigger 1020 is coupled to a piston 1028,which is disposed within a vacuum generation chamber 1030. Rotation ofthe trigger 1020 about the pin 1022 moves the piston 1028 within thevacuum generation chamber 1030. In particular, moving the trigger 1020towards the housing 1002 causes the piston 1028 to be pulled out of thevacuum generation chamber 1030. The vacuum generation chamber 1030 iscoupled to a removable tissue trap 1032 through a one-way valve 1034.The one-way valve 1034 allows air to be withdrawn from the tissue trap1032 and into the vacuum generation chamber 1030 when the piston 1028 ismoved distally relative to the vacuum generation chamber 1030. Theone-way valve 1034 further prevents air from entering the tissue trap1032 from the vacuum generation chamber 1030 due to movement of thepiston 1028 proximally relative to the vacuum generation chamber 1030.Another one-way valve 1036 coupled to the vacuum generation chamber 1030allows the vacuum generation chamber 1030 to expel air.

The proximal end 1019 of the inner tubular member 1016 is disposedwithin the tissue trap 1032. In this embodiment, when the inner tubularmember 1016 is in a proximal position, as shown in FIGS. 26(b) and26(c), the proximal end 1019 of the inner tubular member 1016 is insealing engagement with a seal 1037 disposed within the tissue trap1032. For example, the seal 1037 may be a rubber plug, and the proximalend 1019 of the inner tubular member 1016 may be in a sealing engagementwith the plug 1037, so that vacuum created in the tissue trap 1032 isprevented from escaping through the lumen of the inner tubular member1016. When the inner tubular member 1016 is moved in the distaldirection, the seal 1037 unplugs the proximal end 1019 of the innertubular member 1016, and the vacuum within the tissue trap 1032 escapesthrough the hollow inner tubular member 1016, thereby subjecting tissueadjacent to the tissue resection window 1014 to vacuum and pulling thetissue into the window 1014.

It should be well understood that the device 1000 could alternatively beconfigured such that the proximal end 1019 of the inner tubular member1016 is in a sealing engagement with a seal in the tissue trap 1032 whenthe inner tubular member 1016 is in a distal position, rather than aproximal position. In this alternative embodiment, the sealingengagement between the proximal end 1019 of the inner tubular member1016 and the seal is opened when the inner tubular member 1016 is movedin a proximal direction relative to the housing 1002. In thisalternative embodiment, vacuum is created within the tissue trap 1032while the tissue resection window 1014 is closed.

The trigger 1020 is selectively operatively coupled to the inner tubularmember 1016 by a sliding lever, or slider, 1038 coupled to the housing1002. As shown in FIG. 26(a), the slider 1038 is configured for allowinga user to choose between “vacuum mode” and “cutting mode.” In order toput the device 1000 in vacuum mode, the slider 1038 is displaced in aproximal position relative to the housing 1002, and in order to put thedevice 1000 in cutting mode, the sliding 1038 is displaced in a distalposition relative to the housing 1002.

FIG. 26(b) depicts the device 1000 in vacuum mode, with the slider 1038in its proximal position. When the device 1000 is in vacuum mode,actuation of the trigger 1020 pulls the piston 1028 distally within thevacuum generation chamber 1030, thereby pulling air out of the tissuetrap 1032 through the one-way valve 1034 and creating a vacuum withinthe tissue trap 1032. When the trigger 1020 is released and pushed awayfrom the housing 1002 by the spring 1023, the piston 1028 movesproximally through the vacuum generation chamber 1030, and air isthereby expelled from the chamber 1030 through the other one-way valve1036. The trigger 1020 may be pumped several times to create sufficientvacuum within the tissue trap 1032. Alternatively, the device 1000 maybe configured so that sufficient vacuum is created within the tissuetrap 1032 with only a single squeeze of the trigger 1020.

In yet another alternative embodiment, rather than creating vacuumwithin the tissue trap 1032 that is later released through the innertubular member 1016, the vacuum created by squeezing the trigger 1020may immediately be applied to the tissue through the inner tubularmember 1016. Thus, each time the trigger 1020 is squeezed, tissue ispulled into the resection window 1014. This embodiment does not requirethe seal 1037 between the proximal end 1019 of the inner tubular member1016 and the tissue trap 1032.

After sufficient vacuum is created within the tissue trap 1032, thevacuum may be released and applied to tissue in order to suction tissueinto the tissue resection window 1014, and the tissue within the window1014 may be cut by putting the device 1000 in the cutting mode. In orderto release the vacuum and cut the tissue, the slider 1038 is moveddistally relative to the housing 1002 to put the device 1000 in cuttingmode, as shown in FIG. 26(c). Switching to cutting mode may cause thetrigger 1020 to become disengaged from the piston 1028. However, in thisembodiment, the trigger 1020 remains coupled to the piston 1028 when thedevice 1000 is in cutting mode. As such, vacuum is created each time thetrigger 1020 is actuated. In cutting mode, actuation of the trigger 1020causes the first end 1024 of the trigger 1020 to contact the slider 1038and push the slider 1038 in the distal direction. The distance coveredby the slider 1038 during actuation of the trigger 1020 is approximatelyequal to the length of the window 1014 in the outer tubular member 1008.The slider 1038 contacts a block 1040 fixedly coupled to the innertubular member 1016 so that distal movement of the slider 1038 causesdistal movement of the inner tubular member 1016. As discussed above,distal movement of the inner tubular member 1016 breaks the seal betweenthe proximal end 1019 of the inner tubular member 1016 and the tissuetrap 1032, so that the vacuum created within the tissue trap 1032 isapplied to tissue through the inner tubular member 1016. The vacuumapplied through the inner tubular member 1016 causes tissue adjacent tothe window 1014 to be pulled into the window 1014. Further distalmovement of the inner tubular member 1016 causes the distal end 1018 ofthe inner tubular member 1016 to move across the window 1014, therebysevering the tissue extending into the window 1014. The severed tissueis suctioned proximally through the inner tube 1016 and into the tissuetrap 1032. When the trigger 1020 is released and restored to itsoriginal position by the spring 1023, the inner tubular member 1016 isrestored to the proximal position shown in FIGS. 26(b) and 26(c) by thespring 1042. At the completion of the tissue removal procedure, thetissue trap 1032 with the removed tissue therein is removed from thehousing 1002.

FIGS. 27(a) and 27(b) depict another embodiment of a tissue removaldevice 1100. Similar to the tissue removal device 1000 depicted in FIGS.26(a)-26(c), the tissue removal device 1100 in this embodiment is notattached to a motor unit or a vacuum source. Rather, the tissue removaldevice 1100 includes manually operated assemblies, described in furtherdetail below, for creating vacuum and for cutting tissue.

Tissue removal device 1100 is similar in many respects to the tissueremoval devices previously described herein. For example, similar to theother tissue removal devices described herein, tissue removal device1100 includes a housing 1102 having a distal end 1104 and a proximal end1106, an outer tubular member 1108 having a proximal end 1110 coupled tothe distal end 1104 of the housing 1102 and a distal end 1112 having atissue resection window 1114, and an inner tubular member 1116configured for sliding within the outer tubular member 1108. The outertubular member 1108 is configured for transcervical insertion.Additionally or alternatively, the outer tubular member 1108 isconfigured for insertion through a working channel of an endoscopicinstrument so that the tissue resection window 1114 is positioned in aninterior region of a patient's body. The distal end 1112 of the outertubular member 1108 may be conformable or rigid. The outer tubularmember 1108 may be configured to rotate relative to the housing 1102.The inner tubular member 1116 is hollow, and includes an open distalend, an open proximal end, and a lumen extending between the open distalend and the open proximal end. The distal end of the inner tubularmember 1116 includes a cutting edge for severing tissue projecting intothe tissue resection window 1114.

However, whereas the other tissue removal devices described herein areconfigured for being operated while attached to a vacuum source and/or amotor unit, the tissue removal device 1100 is completely manuallyoperated. Thus, the tissue removal device 1100 is “tetherless,” becauseit does not require tubes or cables for connecting the device 1100 to avacuum source and/or a motor unit.

Similar to the tissue removal device 1000 depicted in FIGS. 26(a)through 26(c), the tissue removal device 1100 includes a vacuumgeneration chamber 1120 coupled to a tissue trap 1122 through a one-wayvalve (not shown). The one-way valve allows air to be withdrawn from thetissue trap 1122 and into the vacuum generation chamber 1120, and alsoprevents air from entering the tissue trap 1122 from the vacuumgeneration chamber 1120. The tissue removal device 1100 also includesanother one-way valve (not shown), similar to the one-way valve 1036 inthe device 1000, coupled to the vacuum generation chamber 1120 forallowing air to be expelled from the vacuum generation chamber 1120.

The proximal end of the inner tubular member 1116 is disposed within thetissue trap 1122. Similar to the embodiment shown in FIGS. 26(a)-26(c),when the inner tubular member 1116 is in a proximal position, theproximal end of the inner tubular member 1116 is in sealing engagementwith a seal (not shown) disposed within the tissue trap 1122. Forexample, the seal may be a rubber plug (not shown), and the proximal endof the inner tubular member 1116 may be in a sealing engagement with theplug, so that vacuum created in the tissue trap 1022 is prevented fromescaping through the lumen of the inner tubular member 1116. When theinner tubular member 1116 is moved in the distal direction, the seal isopened, and the vacuum within the tissue trap 1122 escapes through thehollow inner tubular member 1116, thereby subjecting tissue adjacent tothe tissue receiving window 1114 to vacuum and pulling the tissue intothe window 1114.

It should be well understood that the device 1100 could alternatively beconfigured such that the proximal end of the inner tubular member 1116is in a sealing engagement with the seal in the tissue trap 1122 whenthe inner tubular member 1116 is in a distal position, rather than aproximal position. In this alternative embodiment, the sealingengagement between the proximal end of the inner tubular member 1116 andthe seal would be opened when the inner tubular member 1116 is moved ina proximal direction relative to the housing 1102. In this alternativeembodiment, vacuum is created within the tissue trap 1122 while thetissue resection window 1114 is closed.

The vacuum generation chamber 1120 is coupled (e.g., through a piston)to an actuator in the form of an actuation member, such as a ring 1128,disposed around a tubular portion of the housing 1102, and configuredfor sliding axially relative to the housing 1102. The ring 1128 iscoupled to the vacuum generation chamber 1120 in a manner such thatpulling the ring 1128 proximally relative to the housing 1102 createsvacuum in the tissue trap 1122 by pulling air out of the tissue trap1122 through the one-way valve between the chamber 1120 and the tissuetrap 1122. The ring 1128 may be spring-biased in the distal position, ormay be manually moved between the proximal and distal positions. Whenthe ring 1128 returns to the distal position, air is expelled from thevacuum generation chamber 1120 through the other one-way valve (notshown). The ring 1128 may be moved back and forth relative to thehousing 1102 several times to create sufficient vacuum within the tissuetrap 1122, or the device 1100 may be configured to that sufficientvacuum is created within the tissue trap 1122 by sliding the ring 1028proximally one time.

After sufficient vacuum is created within the tissue trap 1122, thevacuum may be released and applied to tissue in order to suction thetissue into the tissue resection window 1114, and the tissue within thewindow 1114 may be cut. In order to release the vacuum and cut thetissue, a sliding button, or slider, 1132 coupled to the housing 1102and fixedly coupled to the inner tubular member 1116 is moved in thedistal direction relative to the housing 1102, which causes the innertubular member 1116 to move distally relative to the outer tubularmember 1108. Similar to the embodiment shown in FIGS. 26(a)-26(c),moving the inner tubular member 1116 in the distal direction opens theseal between the proximal end of the inner tubular member 1116 and thetissue trap 1122 so that the vacuum created in the tissue trap 1122 isapplied through the inner tubular member 1116 and tissue is pulled intothe window 1114 in the outer tubular member 1108. The inner tubularmember 1116 continues to move in the distal direction until the window1114 is closed and the tissue is severed. The severed tissue issuctioned proximally through the inner tubular member 1116 and into thetissue trap 1122. When the slider 1132 is moved back to the proximalposition, the inner tubular member 1116 is pulled back proximally intothe proximal position. The slider 1132 and/or the inner tubular member1116 may be spring-loaded to return to the proximal position without anyaction from the user, or may be manually returned to the proximalposition. At the completion of the procedure, the tissue trap 1122 withthe removed tissue therein is removed from the housing 1102.

Conditional language, such as, among others, “can,” “could,” “might,” or“may,” unless specifically stated otherwise, or otherwise understoodwithin the context as used, is generally intended to convey that certainembodiments include, while other embodiments do not include, certainfeatures, elements and/or steps. Thus, such conditional language is notgenerally intended to imply that features, elements and/or steps are inany way required for one or more embodiments or that one or moreembodiments necessarily include logic for deciding, with or without userinput or prompting, whether these features, elements and/or steps areincluded or are to be performed in any particular embodiment. Theheadings used herein are for the convenience of the reader only and arenot meant to limit the scope of the inventions or claims.

Although this disclosure has been provided in the context of certainembodiments and examples, it will be understood by those skilled in theart that the disclosure extends beyond the specifically disclosedembodiments to other alternative embodiments and/or uses of theembodiments and obvious modifications and equivalents thereof.Additionally, the skilled artisan will recognize that any of theabove-described methods can be carried out using any appropriateapparatus. Further, the disclosure herein of any particular feature,aspect, method, property, characteristic, quality, attribute, element,or the like in connection with an embodiment can be used in all otherembodiments set forth herein. Thus, it is intended that the scope of thepresent inventions disclosed herein should not be limited to theillustrated and/or described embodiments.

What is claimed is:
 1. A method for resecting tissue from a uterus usinga surgical device, the surgical device comprising a housing, a vacuumchamber located in the housing, a manually-operated actuatormechanically coupled to a piston disposed in the vacuum chamber, anouter tube having a sidewall opening near a distal end of the outertube, and an inner tube, the inner tube being positioned within a lumenof the outer tube, the inner tube having a lumen in selective fluidcommunication with the sidewall opening in the outer tube via a distalopening in the inner tube, the method comprising: transcervicallyintroducing a distal portion of the surgical device into the uterus sothat the sidewall opening in the outer tube is positioned adjacent touterine wall tissue targeted for removal; applying a force to themanually-operated actuator to move the piston and thereby generatevacuum in the vacuum chamber and cause the targeted uterine wall tissueto prolapse into the sidewall opening; and after generating vacuum inthe vacuum chamber and causing the targeted uterine wall tissue toprolapse into the sidewall opening, initiating translation of the innertube relative to the outer tube to thereby cut the targeted uterine walltissue.
 2. The method of claim 1, wherein translating the inner tuberelative to the outer tube distally severs the target tissue.
 3. Themethod of claim 1, wherein manual actuation of the actuator initiatestranslation of the inner tube relative to the outer tube.
 4. The methodof claim 1, further comprising rotating the outer tube relative to thehousing for positioning or repositioning the sidewall opening.
 5. Themethod of claim 1, wherein the outer tubular member is conformable. 6.The method of claim 1, wherein the method comprises manually actuatingthe actuator a first time to generate vacuum in the vacuum chamber, andthereafter manually actuating the actuator a second time to initiatetranslation of the inner tube relative to the outer tube.
 7. The methodof claim 1, wherein the inner tube is translated without moving thepiston.
 8. The method of claim 1, further comprising coupling theactuator to the inner tube before initiating translation.
 9. A methodfor resecting tissue from a uterus using a surgical device, the surgicaldevice comprising a housing, a vacuum generator located in the housing,an outer tube having a sidewall opening near a distal end of the outertube, and an inner tube, the inner tube being positioned within a lumenof the outer tube, the inner tube having a lumen in selective fluidcommunication with the sidewall opening in the outer tube via a distalopening in the inner tube, the method comprising: transcervicallyintroducing a distal portion of the surgical device into the uterus sothat the sidewall opening in the outer tube is positioned adjacent touterine wall tissue targeted for removal; manually actuating the vacuumgenerator to mechanically generate vacuum within a vacuum chamberfluidly coupled to the lumen of the inner tube; and after generatingvacuum in the vacuum chamber, initiating translation of the inner tubedistally relative to the outer tube to cause the targeted uterine walltissue to prolapse into the sidewall opening and to thereby sever theprolapsed uterine wall tissue.
 10. The method of claim 9, wherein thesurgical device includes a trigger operably coupled to the housing, andwherein manually actuating the vacuum generator comprises manuallyactuating the trigger.